[awsmjobs]
Utility Commissioning Field Engineer (3 spots)
2-5 years’ experience in starting up Utility systems – Pharma / Oil & Gas
- Be part of a team of engineers to develop operation verification test scripts.
- Help develop Startup Logic and handover prioritization.
- Assist in the development of startup activities such as flushing / pressure testing plans and system livening.
- Understands generic LOTO procedures.
- Has experience with execution on installation verification and operation verification execution.
- Has exposure to working with vendors.
Additional: DeltaV experience, Kneat experience, PQ experience
REVIT experience - Smart PID and Plant PD
* * REVIT experience and updating models not on the design aspect more of the manipulation of the models themselves
Copying sheets between project more of the model admin
Not so much designing but to manipulate the models
Job Summary/Position Overview
- The CAD/BIM Services Coordinator will play a crucial role in managing and optimizing the use of Computer Aided Design (CAD) and Building Information Modeling (BIM) technologies. This position is responsible for maintaining and managing central models, facilitating collaboration among stakeholders, and ensuring that all CAD and BIM processes align with organizational standards. The ideal candidate will work closely with project teams to streamline workflows, enhance data integrity, and support the successful execution of projects. A strong technical background in CAD/BIM technologies, excellent communication skills, and a proactive approach to problem-solving in a fast-paced environment are essential for this role.
Major Accountabilities
- Collaborate with IT to implement BIM/CAD systems, manage Autodesk license compliance and availability for users, and ensure timely updates and software availability for specific Autodesk products.
- Ensure BIM deliverables comply with GMP documentation and validation requirements.
- Establish clear audit trails for all model and data changes.
- Develop and maintain Client Information Requirements (CIR) with a GMP focus.
- Enforce compliance with site-specific digital procedures.
- Audit supply chain BIM Execution Plans (BEPs) to confirm they address critical systems.
- Oversee Common Data Environment (CDE) ensuring secure, validated, and access-controlled information flows.
- Confirm metadata includes equipment IDs, materials, cleaning validation requirements, and other regulated attributes.
- Act as the client representative with design teams, contractors, and validation engineers.
- Assign equipment tags, line numbers and drawing numbers in accordance with the standard.
- Manage change control processes, ensuring that any digital model or data change is reflected in GMP documentation.
- Organizes, develops, and maintains Engineering and Facility documentation and drawings
- Provides BIM/CAD support to Engineering, Maintenance, and Facility projects regarding the creation, revision, and handling of drawing lists, valve lists, line schedules, work orders, and other activities
- Creates and revises BIM documentation for both Good Manufacturing Practices (GMP) and non-GMP requests
- Trains BIM/CAD staff on core application skills and standards
- Trains BIM service users on procedures
- Collaborates with other sites to ensure alignment across the company
Knowledge, Skills, or Abilities:
- Proficient knowledge in 3D model environments and Autodesk applications (Plant3d, AutoCAD, ACC)
- Effective communication, both written and oral
- Ability to operate and control the local BIM system, databases, libraries, and archives
- Ability to manage competing priorities in a fast paced environment
- Self-driven and takes ownership of tasks and team assignments
2-5 years’ experience in Commissioning and Qualification – Pharma
- Be part of a team of engineers to develop operation verification test scripts.
- Help develop Startup Logic and handover prioritization.
- Assist in the development of startup activities such as flushing / pressure testing plans and system livening.
- Understands generic LOTO procedures.
- Has experience with execution on installation verification and operation verification execution.
- Has exposure to working with vendors.
Additional: DeltaV experience, Kneat experience, PQ experience
Responsibilities:
Work to support the ITOT System owners in tasks associated with the lifecycle of computer system, ie. maintenance, validation, documentation, testing.
Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model.
Help perform MILE (annual system maintenance) activities for ITOT Systems. For example, create, update, execute, or review installation protocols, test protocols, etc.
Own Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed.
Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports.
Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems.
Support validation activities, generation, approval and execution of validation protocols
Assist System Owners in system maintenance activities such as Periodic System Audit Trail Review, account audits, etc.
Creating reports for various systems on demand
Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance.
Support on documents management systems (Veeva, Condor, eVal)
Support the team with administrative tasks, such as document formatting, document routing.
Collaborate with local and global stakeholders in defining and completing validation and compliance activities.
Attend Quality Huddle Meetings
Provide Quality Metrics
Align with global Validation protocols and policies
Minimum Requirements:
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
Minimum 5 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.
Knowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development,
Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus.
Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles.
Good understanding of system and data integrity risk assessment concepts.
Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products and/or processes.
Conducts quality control for statistical analyses of testing results and process anomalies.
Ensures that corrective measures meet acceptable reliability standards.
Verifies calibration, maintenance, and repair of instruments as applicable to support the Quality Systems validation program.
May evaluate quality and system standards to ensure reliability and compliance with company standards and government regulatory requirements.
Responsibilities:
1 Maintain a thorough understanding of the relevant regulations and guidelines: Food & Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Practices (cGMP), corporate policies and procedures, FDA's guidance on Validations, all relevant Medical Device Directives, and other applicable standards.
2 Under direct supervision, assists in preparation, execution, data collection, and reporting of validation studies to ensure the user needs and specifications are consistently met.
3 Prepares validation protocols and test equipment; evaluates validation test data.
4 Prepares reports on completed studies that summarize test results and their conformance to defined acceptance criteria.
5 Assists in developing programs and maintaining standard operating procedures (SOPs)validations.
6 May provide support related to management of procedural documents.
7 Communicates cross functionally regarding needs and status of assigned study activities and project deliverables.
8 Perform other job-related duties as assigned.
Manager's Notes:
Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to systems, products, and/or processes.
Conducts quality control for statistical analyses of testing results and process anomalies.
Ensures that corrective measures meet acceptable reliability standards.
Verifies calibration, maintenance, and repair of instruments as applicable to support the Quality Systems validation program.
May evaluate quality and system standards to ensure reliability and compliance with company standards and government regulatory requirements
Requirements:
Bachelor’s degree in sciences or engineering or equivalent combination of education, training and relevant work experience required
3+ years' related quality/validation experience in pharmaceutical manufacturing/a highly regulated industry
In-depth working knowledge of cGMP principles and applications
Demonstrated ability writing and approving documents, which help explain technologies, processes and products including validations
Participating in FMEA or RCA/CAPA development teams
Understand regulatory standards, various local, state, and federal laws that apply to the business and where to find information on standards and interpretations
Excellent negotiating, critical reasoning, decision-making, and problem-solving skills to analyze situations, determine risks, find solutions to prevent future issues and resolve recurring defects
Strong project management and organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
Strong written and verbal communication, interpersonal and presentation skills to drive results
Establish solid working relationships to interface with other business units, third parties and other positions and circumstances within the organization
Demonstrates excellent customer service skills with the flexibility to respond to changes quickly
Maintain a professional demeanor and handle confidential information with discretion
Computer literate with proficiency in office applications, word processing, spreadsheets, graphics and statistical programs, and use of electronic quality and operational systems
ASQ Certification preferred
Minimum 3 years related experience & bachelor's degree in science or engineering
Equivalent combination of education, training, & related experience can be considered in lief of bachelor's degree requirement
Description:
***This is an onsite position
* This individual will serve as the Product Owner for Test, responsible for defining and driving the overall strategy for the testing campaign.
* The ideal candidate must function as a strategic thought leader, and not as a tactical tester.
* Requires a minimum of 8 years of experience in software testing for hardware-integrated systems.
* Experience in a FDA or FAA regulated environment is a strong plus; Medical device industry is ideal
Key Responsibilities
*Define Strategy & Vision: Serve as the team leader by translating customer needs into technological solutions and contributing to strategic direction through technical knowledge and creative application.
*Own Backlog & Prioritization: Manage, build, and prioritize the team's backlog; detail user stories; and coordinate cross-team dependencies in preparation for Program Increment (PI) and iteration planning.
*Drive Acceptance & Delivery: Formally accept and approve all team features and user stories, leveraging acceptance criteria and a defined "definition of done" to ensure quality deliverables.
*Lead Team Processes: Facilitate cross-functional collaboration, advocate for built-in quality and customer-centric design, and participate in continuous improvement activities like Inspect and Adapt events.
*Represent & Communicate: Present project results both internally and externally, and present complex technical data to diverse stakeholder groups.
Instrument Validation for Quality Control and Manufacturing Instrumentation
Provide support related to Instrument Validation for Quality Control and Manufacturing Instrumentation in the QC and manufacturing labs within the department.
1. Validation Plan
- Develop comprehensive validation plans outlining the strategy, scope, objectives, responsibilities, and acceptance criteria for the qualification of equipment and systems.
- Define timelines, resources, and documentation requirements to align with regulatory and internal quality standards.
2. User Requirements Specifications (URS)
- Prepare URS documents detailing the functional, operational, and performance requirements for the equipment and systems under validation.
- Collaborate with stakeholders to ensure all critical requirements are captured and align with the intended use.
3. Installation, Operational, and Performance Qualification Protocols (IQ/OQ/PQ)
- Develop and execute qualification protocols (IQ, OQ, PQ) for the designated equipment or systems.
- IQ: Verify installation against specifications, including utilities, components, and connections.
- OQ: Test operational parameters to confirm they meet design and functional requirements.
- PQ: Validate performance in a simulated or actual operational environment to ensure consistent functionality and reliability.
4. Summary Reports
- Draft summary report for systems being validated, consolidating results, observations, deviations, and conclusions.
- Ensure reports demonstrate compliance with acceptance criteria and readiness for operational use.
5. ERES Assessments
Conduct and document Electronic Records and Electronic Signatures (ERES) assessments to ensure compliance with 21 CFR Part 11 and equivalent regulations.
- Evaluate data integrity, audit trails, security, and system controls for the system.
- Provide recommendations for any necessary remediation or procedural updates.
This scope ensures robust validation of equipment and systems to meet regulatory and operational requirements.
Requirements:
- Follow the Change control process and manage any deviations or non-conformities identified during instrument validation activities, including investigation, root cause analysis, and implementation of corrective actions.
- Participate in projects and special assignments as they develop.
- Provide technical support as required and support ongoing investigations.
- Maintain inspection readiness.
- Provide routine status reporting as required.
Deliverables or Milesones:
- Reporting: Provide weekly project and activity status updates on deliverables.
- Support/Implementation: Provide support for the QC and APO Validation Program and associated Validation projects, Including windows 10 upgrades.
- Documentation: Plan and coordinate the validation/qualification work assigned, including Validation Plans, Validation Strategy, Requirements Specifications, Qualification protocols, and Impact / Risk Assessments.
- Closeout: Provide final monthly summary of validation activities and completion status.
I am looking for up to 4 PMs, one each for MEP/process utilities, CSA - civil structural and architectural, upstream peptide synthesis and downstream peptide purification. The upstream and downstream roles are heavily pharmaceutical process equipment / manufacturing suite centric, while the MEP and CSA roles are inclusive of scope across the building. GMP is a must.
The Project Manager provides governance oversight and decision authority and serves as the primary
interface with the General Contractor.
This role leads through authority, prioritization, and decision clarity. The PM does not act as a
discipline SME, system engineer, or construction manager. Technical authority resides with System
Owners. Execution authority (means, methods, sequencing, manpower deployment) resides with the
General Contractor.
This is a site-based role reporting to the Project Director. The role ensures timely decisions, approved
change control, accurate cost and schedule performance, and that the contractor has the necessary
inputs and support to deliver the project safely, on time, and within budget.
2.0 ACCOUNTABILITIES
· Serving as the primary day-to-day governance interface for the General Contractor, maintaining
regular face-to-face engagement, being accessible, responsive, decisive, and proactively
determining disposition and escalation pathways for issues / queries to maintain project progress.
· Ensuring that the project is delivered safely and in full compliance with Client and external
Environment, Health, and Safety (EHS) requirements.
· Providing effective management by setting and communicating clear project expectations to the
project team on scope, design, schedule, costs, and project change management.
· Maintaining daily visibility of project activities to validate priorities, commitments, readiness, and
risk exposure. Identifies sequencing impacts, resource constraints, and emerging risks and
escalates through appropriate governance channels. (The PM does not own field sequencing or
manpower deployment.)
· Serving as the primary governance, prioritization, and escalation interface to the General
Contractor.
3.0 RESPONSIBILITIES
· Maintains structured and transparent engagement with the General Contractor to support
governance decisions and issue disposition.
· Understands and works in full compliance with all Client Project Management processes. · Provides decisive and accountable management, setting and communicating clear expectations to the project team regarding scope, design intent, schedule, cost, and change management. · Effectively manages project change requests by assessing impact on scope, budget, and schedule and communicates the outcome to the change requester and General Contractor. o Technical disposition remains with the System Owner. o Execution impacts remain with the General Contractor. o Final approval authority resides with the PM within delegated governance thresholds. · Effectively manages Project Deviation Notices (PDNs) with the General Contractor and coordinates approval when a PDN is raised. · Delivers the project on schedule, within budget, and to the approved scope and quality standards through effective governance, prioritization, and escalation. · Monitors approved contracts, and where issues arise, collaborates with procurement and General Contractor to identify and implement corrections to improve performance. · Reinforces and ensures adherence to approved safety programs led by the EHS function. Create a culture of safety within the team, and where safety issues arise, ensure timely resolution through appropriate responsible functions. · Maintains disciplined governance of project risks, costs, and schedule performance, ensuring corrective actions are defined, assigned, and executed by the responsible party, and escalated where required. · Provides accurate and timely reporting of project performance, progress, risks, and cost status to senior leadership and stakeholders. Issues monthly progress and cost reports. · Drives continuous improvement and innovation, identifying lessons learned and best practices to enhance project performance and organizational capability. · Chairs weekly project team meetings and holds project team members accountable for project delivery, preparing focused meeting agendas with attendees to enable effective decision-making. · Attends project steering meetings, presenting status, schedule, risks, and lookaheads for the specific project scope. · Maintains daily governance visibility to ensure contractor commitments, priorities, and escalation pathways are clear and aligned with approved scope and schedule. · In responding to escalations from Construction, System Owners, or C&Q, the PM determines disposition and escalation path. Execution of corrective actions remains the responsibility of the Contractor. The Project Manager shall not: · Direct contractor superintendents, foremen, or craft labor · Re-sequence field work or assign manpower · Issue instructions directly to contractor discipline supervisors · Commit contractor to cost or schedule impacts
4.0 COMPETENCIES
· Bachelor’s degree in Engineering, Construction Management, Project Management, or a related technical discipline (Master’s degree preferred). · Minimum of 10 years’ experience delivering large-scale pharmaceutical, biotechnology, or life sciences capital projects valued between $500 million and $2 billion, ideally within a greenfield environment. · Proven experience managing EPC or General Contractors on complex, highly regulated construction projects. · Demonstrated end-to-end project delivery capability across design, construction, commissioning, and handover phases. · Strong understanding of pharmaceutical manufacturing facilities, GMP requirements, and regulated environments. · Expertise in project management governance, including schedule control, cost management, risk management, change control, contract administration, and procurement strategy. · Highly effective leader and communicator, with strong negotiation and conflict resolution skills and the ability to operate decisively in fast-paced, high-pressure project environments
Our client is looking for the following for 12 months.
o Construction System Owner- CSA (Civil, Structural, Architectural)
o Construction System Owner- Mechanical & HVAC
o Construction System Owner- Piping
o Construction System Owner- E&I (Electrical & Instrumentation)
o Construction System Owner- Equipment
The Construction System Owner – CSA (Civil, Structural, Architectural) is accountable for the execution
and delivery of all CSA scope during the construction phase of the project. This includes oversight of
civil works, structural systems, and architectural installations to ensure full compliance with approved
drawings, technical specifications, validated submittals, and applicable GMP and regulatory
requirements.
The role maintains accountability for safety performance, construction quality, and adherence to
established design and compliance standards throughout execution.
The role has technical experience, construction management experience, will have field oversight,
contractor performance, quality control, and schedule adherence from construction through
completion and turnover to Client ops.
This role ensures CSA systems are fully coordinated, documented, and ready for testing, verification,
occupancy, and final handover.
2.0 ACCOUNTABILITIES
Be the single point of contact for the Project director for CSA delivery and turnover.
Monitoring and check Main Contractor complies with:
· Current IFC design,
· Safe means and methods
· Regulatory EHS/OSHA requirements
· Client requirements
· Responding to RFI, Submittals in a timely fashion
· Schedule, Cost, Quality
· Informing project of new Schedule, Cost, Quality risks and concerns
· Out of Sequence works
This will be done while fostering strong contractor alignment on safety, quality, schedule, and Right-
First-Time (RFT) delivery.
Providing daily oversight of CSA construction activities, verifying compliance with approved IFC
drawings, specifications, and submittals, and promptly escalating deficiencies or non-conformances.
Monitoring the contractors field controls including daily logs of labor, equipment, productivity, and
tracking of RFIs, punch list items, safety observations, and field changes.
Monitoring CSA readiness for walkdowns and substantial completion, ensuring accurate documentation, as-built verification, and turnover package completeness. Identify required resources from the contractor or Client, to support the construction effort eg maybe a specialist cleanroom architect is required or support for architectural finishes is needed during walkdowns/turnover. Supporting regular meeting cadence, and reporting.
3.0 RESPONSIBILITIES
· Support on-site technical and quality oversight of all CSA construction activities, ensuring
compliance with drawings, specifications, standards, and approved submittals.
· Identify and resolve CSA risks, conflicts, and deviations in coordination with contractors and
engineering.
· Witness, inspect, and verify architectural and structural works, ensuring GMP compliance for
cleanrooms, finishes, partitions, and environmental controls.
· Ensure temporary barriers, housekeeping, dust control, and access controls meet operational and
project standards.
· Audit installation records, inspection reports, and quality documentation, supporting
commissioning and qualification readiness.
· Monitor daily CSA progress, identify schedule risks and coordination conflicts, and maintain
detailed field logs of work activities, labor, equipment, and site conditions.
· Document field issues with photographs and provide weekly updates on progress, quality
concerns, open items, and upcoming risks.
· Enforce site safety requirements including PPE, method statements, excavation safety, fall
protection, lifting operations, and temporary works compliance; stop unsafe work when required.
· Attend coordination meetings and communicate field conditions, constraints, and risks to project
leadership.
· Coordinate interfaces between CSA and other trades (MEP, IT, Fire Protection) and support
shutdowns, access restrictions, and staging with facility operations.
· Monitor for critical RFIs and technical queries in collaboration with engineering SMEs.
· Participate/support in walkdowns and substantial completion inspections, manage punch list
closure, verify as-builts, and confirm CSA readiness for turnover and final handover.
4.0 COMPETENCIES
· Bachelor’s in Civil/Structural/Construction Engineering; strong knowledge of IBC, ACI, AISC, and
OSHA standards.
· 10+ years’ site experience delivering CSA scope on large Pharmaceutical / GMP regulated projects.
· Expertise in concrete, structural steel, equipment foundations, underground utilities, and site
development.
· Experience managing cleanroom architectural finishes and building envelope systems. · Skilled in inspections, Substantial Completion walkdowns, punch lists, and turnover documentation. · Strong constructability and multi-discipline coordination (MEP/process interfaces). · Supports commissioning readiness, life-safety coordination, ADA compliance, and occupancy approvals. · Proven safety leadership in excavation, fall protection, crane/lift planning, and temporary works.
The Construction System Owner – Mechanical is accountable for the successful delivery of all
mechanical scope during the construction phase, including mechanical equipment, piping, and HVAC
systems. This accountability includes ensuring compliance with safety standards, approved drawings
and specifications, validated submittals, and applicable GMP requirements, while maintaining the
highest standards of quality and regulatory adherence.
The Construction System Owner – Mechanical has technical experience, construction management
experience, will have field oversight, contractor performance, quality control, and schedule adherence
from construction through MC completion and turnover to C&Q/Client ops.
The Construction System Owner – Mechanical monitors safe execution, schedule performance,
technical quality, and system readiness while maintaining strong contractor alignment and protecting
the critical path.
2.0 ACCOUNTABILITIES
Be the single point of contact for the Project director for Mechanical delivery and turnover.
Monitoring and check Main Contractor complies with:
· Current IFC design
· Safe means and methods
· Regulatory EHS/OSHA requirements
· Client requirements
· Responding to RFI, Submittals in a timely fashion
· Schedule, Cost, Quality
· Informing project of new Schedule, Cost, Quality risks and concerns
· Out of Sequence works
This will be done while fostering strong contractor alignment on safety, quality, schedule, and Right-
First-Time (RFT) delivery.
Providing daily oversight of mechanical construction activities, verifying compliance with approved IFC
drawings, specifications, and submittals, and promptly escalating deficiencies or non-conformances.
Monitoring the contractors field controls including daily logs of labor, equipment, productivity, and
tracking of RFIs, punch list items, safety observations, and field changes.
Monitoring mechanical readiness for walkdowns and substantial completion, ensuring accurate documentation, as-built verification, and turnover package completeness. Owning technical quality and Mechanical Completion activities, including MC walkdowns, punch list closure, NCR resolution, and compliance verification of non-pressure vessel systems. Ensuring high-purity/process piping, vendor packages, and mechanical installations meet GMP, project specifications, and commissioning readiness requirements. Upholding mechanical safety standards, enforcing disciplined work practices while supporting system shakedown, energization, and safe transition into commissioning. Identify required resources from the contractor or Client, to support the construction effort eg maybe a specialist cleanroom architect is required or support for architectural finishes is needed during walkdowns/turnover. Supporting regular meeting cadence, and reporting.
3.0 RESPONSIBILITIES
· Monitor and drive field execution of mechanical utilities, aligning schedule with safe daily/weekly
work fronts and driving construction performance against plan.
· Monitor contractor productivity, manpower, materials, permits, and resources to maintain
momentum and protect the critical path.
· Maintain strong site presence, proactively resolving RFIs, design gaps, clashes, and field
constraints.
· Oversee installation of process piping, high-purity systems, HVAC, ductwork, and mechanical
equipment in compliance with IFC drawings, specifications, and GMP standards.
· Review and verify contractor documentation including pressure test boundaries, test packs, weld
logs, material certifications, and as-builts.
· Ensure high-purity piping fabrication, orbital welding, flushing, passivation, and testing meet
project and regulatory requirements.
· Lead Mechanical Completion walkdowns, inspections, and punch list closure to required quality
standards.
· Support on-site technical and quality oversight of Mechanical construction activities, ensuring
compliance with drawings, specifications, standards, and approved submittals.
· Identify and resolve risks, conflicts, and deviations in coordination with contractors and
engineering.
· Identify and resolve constructability issues early, coordinating with engineering, CQV, contractors,
scheduling, quality, and vendors to drive field issue closeout.
· Lead mechanical safety oversight including pressure testing, LOTO, confined space, suspended
loads, HVAC access, and SIMOPS controls, enforcing site safety and stopping unsafe work when
required.
· Witness, inspect, and verify works, ensuring GMP compliance.
· Ensure temporary barriers, housekeeping, dust control, and access controls meet operational and project standards. · Audit installation records, inspection reports, and quality documentation, supporting commissioning and qualification readiness. · Monitor daily Mechanical progress, identify schedule risks and coordination conflicts, and maintain detailed field logs of work activities, labor, equipment, and site conditions. · Document field issues with photographs and provide weekly updates on progress, quality concerns, open items, and upcoming risks. · Enforce site safety requirements including PPE, method statements, excavation safety, fall protection, lifting operations, and temporary works compliance; stop unsafe work when required. · Attend coordination meetings and communicate field conditions, constraints, and risks to project leadership. · Coordinate interfaces between Mechanical and other trades and support shutdowns, access restrictions, and staging with facility operations. · Monitor for critical RFIs and technical queries in collaboration with engineering SMEs. · Participate/support in walkdowns and substantial completion inspections, manage punch list closure, verify as-builts, and confirm readiness for turnover and final handover. · Confirm vendor packages are fully installed, integrated, and free of constraints prior to commissioning handover. · Support during flushing, energization, startup, shakedown, and integration testing, maintaining system prioritization through TCCC. · Manage custody transfer from EPCM to GFD (or equivalent) and through to Operations, ensuring complete, auditable turnover packages.
4.0 COMPETENCIES
· Bachelor’s in Mechanical Engineering; strong knowledge of ASME B31.3, ASME BPE, GMP, and U.S.
HVAC codes/standards.
· 10+ years’ field experience delivering mechanical and piping systems on large Pharmaceutical
/GMP capital projects.
· Expertise in high-purity/process piping, including orbital welding, weld tracking, hydro/pneumatic
testing, flushing, and passivation.
· Proven oversight of HVAC systems (AHUs, cleanrooms, chillers, ductwork, heat exchangers)
through installation and TAB.
· Experienced in Mechanical Completion walkdowns, punch list closeout, NCR resolution, and
turnover packages.
· Strong commissioning/startup support in coordination with CQV teams and system readiness
(TCCC).
· Skilled in constructability review, contractor oversight, and critical path schedule protection.
· Demonstrated safety leadership in OSHA compliance, LOTO, confined space, and pressure testing
operations.
The Construction Lead will provide independent construction quality and compliance oversight and
ensure alignment between engineering, construction, and C & Q teams, and reinforces standard work
practices across the Project.
The Construction Lead will be the single point of contact for construction on the project and will
report to the Project director. This position provides oversight of the Construction Management (CM)
partner, ensuring disciplined execution, coordination across contractors, and strong field performance
from mobilization and early site works through mechanical completion, commissioning support,
Qualification and Turnover.
The role will act on behalf of the client, ensuring adherence to scope, managing interface issues, and
providing early identification of risks and deviations to the Project Manager and Project Director while
promoting a culture of safety, quality, collaboration, and performance.
The role will ensure the Construction Management (CM) partner have all the necessary input,
approvals, and support to enable them to perform their role effectively, efficiently and deliver the
project on time and within budget.
2.0 ACCOUNTABILITIES
Using influence and strong leadership to drive a collaborative, right-first-time culture that ensures
quality, compliance, and strong EHS performance.
Ensuring construction is executed in accordance with approved designs, standards, and regulatory
requirements, meeting defined scope, quality, and future operational needs.
Monitoring and managing construction progress and contractor performance, recognising good safety
behaviors, tracking schedule, cost, quality, safety, and critical path impacts, and proactively managing
associated risks.
Acting as the primary construction oversight and escalation interface with Fluor and subcontractors,
ensuring construction quality, compliance, and readiness are verified and that risks, deviations, or
interface issues are escalated through the Project Manager for disposition.
Enabling timely system turnover by verifying construction completeness, coordinating turnover logistics, and ensuring construction turnover packages are complete and aligned with C&Q-defined requirements and project milestones. Operating strictly through a verify → escalate → support resolution model, with no authority to direct execution. Resolution actions are owned by onsite Engineering firm and governed by the Project Manager. Ensuring all unresolved execution, sequencing, readiness, or interface disputes with the Construction management Partner are escalated to the Project Manager for resolution and direction. Supporting regular meeting cadence, and reporting.
3.0 RESPONSIBILITIES
· Review construction plans, schedules, and cost forecasts to confirm alignment with project
objectives and delivery milestones.
· Monitor construction cost trends, invoices, and potential change drivers to provide early visibility
of risks or deviations.
· Identify construction risks (schedule, cost, quality, safety) and collaborate with Construction
Management Partner to develop and implement mitigation strategies.
· Implement and enforce quality standards, ensuring all construction activities are Right First Time,
meet design specifications and contractual requirements.
· Lead the team that witness, inspect and verify the quality and compliance of construction work
completed.
· Lead site safety performance ensuring safety plans are implemented, conducting inspections, and
monitoring compliance with regulatory and OSHA requirements.
· Proactively address non-compliance, performing regular safety walkdowns and quality audits.
· Verify construction completeness and coordinate turnover logistics to support early system
completion, documentation readiness, and phased handover in alignment with C&Q-defined
readiness criteria.
· Coordinate turnover logistics to support early system completion, documentation readiness, and
phased handover, without directing or altering construction sequencing, which remains the
responsibility of Construction Management Partner under EPCM execution.
· Coordinate punch list identification and tracking, and escalate unresolved construction and quality
deficiencies to the Project Manager.
· Foster a collaborative “one team” culture between Client, Construction Management Partner,
subcontractors, and stakeholders.
· Lead Client construction personnel overseeing daily construction activities.
· Act as the primary construction liaison, providing clear, regular progress updates to the Project
Manager and PMO Construction Lead and System Owner.
· Routinely assess, monitor, and acknowledge positive safety practices demonstrated by Client, Construction Management Partner contractors and subcontractors and General Contractors to promote and reinforce ongoing improvement in safety performance. · Support Regular meeting cadence, and reporting.
4.0 QUALIFICATIONS & COMPETENCIES
· Bachelor’s degree in Engineering, Construction Management, or related field.
· Minimum 10 years’ experience managing major construction projects valued between $500
million and $2 billion, ideally within pharmaceutical, life sciences, or process industries.
· Proven experience working in a client-side leadership capacity on large, technically complex
programs in a dynamic and high-pressure environment.
· Deep understanding of construction management systems, progress measurement, and reporting
frameworks.
· Strong familiarity with mechanical completion, system turnover, and GMP documentation
requirements.
· Demonstrated expertise in construction methodologies for process equipment, piping systems,
HVAC, electrical, and instrumentation installations.
· Excellent communication, coordination, and stakeholder management skills.
· Recognized professional certification (CEng, PMP, MCIOB, or equivalent).
- This is 1 spot Indianapolis, 1 spot Richmond Virginia, ! spot Huntsville, Alabama on site
The project will be implementing a Verification methodology (ASTM E2500 Model) to Commissioning & Qualification delivery, the approach applies the principles of right people, for the right activity, at the right time. The approach is therefore not a commissioning effort followed by a qualification effort but an integrated and efficient C&Q Program throughout the project lifecycle, from the project design phase through to closeout and handover of systems for operational use. Company uses Kneat™ for electronic C&Q document development and execution. Purpose of the Role: The Company GFD Project C&Q Lead is responsible for providing overall management of all aspects of the C&Q delivery including: • Management of C&Q Scope, Schedule, and Budget. • Oversight and implementation of the defined C&Q Program, ensuring quality delivery. • Planning, scheduling, and management of C&Q FAT, test case development and execution activities. • Technical oversight and guidance to the C&Q team. • Safety oversight of the C&Q team, in conjunction with the project safety group. The GFD Project C&Q Lead will report to the Company GFD Project Manager / Director. The GFD Project C&Q Lead is responsible for ownership of the C&Q program, oversight of the C&Q delivery and representation of C&Q issues with the project leadership team. They will collaborate closely with the GFD Project Manager, end‑user representatives, construction, automation, QA, and project controls to fully understand the project scope, delivery approach, and overall schedule. Using this knowledge, they will develop the detailed C&Q delivery strategy and schedule, then lead and manage its execution to ensure the C&Q scope is delivered on time, within budget, and to the required quality standards. This includes coordinating with other disciplines, influencing and guiding cross‑functional teams, and reporting progress through the agreed C&Q performance metrics. The GFD Project C&Q Lead will plan the execution strategy and logistics for FATs, test case development, and field execution. This will include defining appropriate staffing levels, travel logistics, test equipment, craft support, as well as managing the team on a day to day basis during these activities. They will also maintain safety oversight during these activities including ensuring implementation of safety and permitting procedures, and method statements. They will ensure that the required level of technical excellence is maintained throughout the course of the project. In all cases, they will provide oversight and guidance to assure the work of their team is well coordinated with the end-user representative, construction, automation and QA to address technical and compliance questions and to facilitate their resolution. Role Responsibilities • The GFD Project C&Q Lead is expected to have a working technical knowledge and experience base of the systems expected in the facility to ensure adequate oversight during C&Q delivery. • The GFD Project C&Q Lead is expected to review and understand the existing Company C&Q program to a level of detail sufficient to adequately train the project team and manage the implementation of the program. • Manage C&Q scope, budget and schedule. • Management of C&Q team, including daily meetings, task assignments, and delegation. • Provide technical oversight and program management as needed to assure technical work quality and progress of the C&Q team. • Escalate issues that are not promptly resolved by team, including delayed approval of C&Q documents, field execution issues, or alignment problems with other disciplines. • Train project team and service providers as required to support commissioning and verification. • Work collaboratively with project support groups (e.g. automation, construction, engineering, end user, QA) and their management and opinion leaders to influence decisions and facilitate completion of the C&Q work. • Scope and manage sourcing of test equipment and craft support required for field testing. • Manage and report on team workload and progress. • Provide monthly progress metrics to the project leadership team. • Ensure the C&Q team abide by all project safety requirements and procedures pertaining to their role and supplement the safety program to cover C&Q specific activities as applicable; serve as a positive model to others in this regard. Role Requirements: • BS Engineering (or equivalent experience) • +15 years C&Q experience within Major or Mega Pharmaceutical Project Delivery. • Experience as a C&Q Manager in the delivery of at least one Brownfield or Greenfield pharmaceutical facility, covering the full lifecycle from early design and initial team formation through field execution, system turnover, and project closeout. • Demonstrated leadership and people management skills. • Knowledge of GMP’s, regulatory requirements, commissioning, qualification and ASTM E2500 Verification Approach. • Good written and verbal communication skills with both technical and non-technical team members. • Travel: site based full time.
Location: Maryland
Duration: 6 Months
Start:End of September
Current issue: people are not lightening the load- supposedly mid level, but they can't do anything independently even after being given time
SCADA system: Rockwell( biggest), Ignition
OSI PI Historian- data management
Industrial network- IO link, Ethernet communications, DeviceNet
various software with their standalone equipment
most processes are under 2000L bioreactors (so mid - level mfg)
*They do both continuous and batch processing
*Need to be able to Gown-in, specifically an ISO 7 cleanroom
*GMP focus and change management experience
*Awareness of scheduling impact on production based on equipment's being brought down.
Duties: start off with developing URS based off of end users, talk to quality department (determine and understand impact on existing systems and how to capture changes), then more of the technical part would need to be done... prepare this phase/ equipment module, landing module I/O input from PLC or equipment and make it do X.
Great - here is the JD (it may differ slightly over many renditions) and the profile we discussed:
- Project management for automation project requests. ECMS quality change control system. Preferred experience with project management tools (e.g. Smartsheets).
- Respond to on-demand troubleshooting requests from Manufacturing and/or ES&T. Escalate outstanding issues to ES&T automation and Manufacturing area management.
- SAP Planner Responsibilities – closing out WOs / PMs
- Be assigned the Automation subject matter expert (SME) for GMP area(s).
- Maintain and establish Data Integrity standards for Validated systems.
- Manage external vendors ensuring execution of projects and tasks.
Required: communication is critical in this position, which is why I am asking for fluent speaking / graduated from a university from USA.
MPD Planner/Scheduler
A MPD (Maintenance Package Delivery) Planner/Scheduler performs planning and scheduling functions for new construction asset delivery task in a GMP pharmaceutical environment. They are responsible for planning and scheduling asset delivery activities to ensure compliance with regulatory standards and support uninterrupted operations up through TC and TCCC. This role typically requires a background in project management, knowledge of pharmaceutical processes, and experience with scheduling software. This role will be reporting directly to the MPD (Maintenance Package Delivery) Lead.
Overview of Planner/Scheduler Role
A planner/scheduler in a GMP (Good Manufacturing Practice) pharmaceutical environment plays a crucial role in ensuring that new construction asset delivery aligns with regulatory standards and operational needs. This position focuses on planning and scheduling asset delivery activities to support uninterrupted ramp-up operations for a new greenfield site.
Key Responsibilities
Planning and Scheduling
- Develop and maintain detailed schedules for asset delivery RE/RCM (Reliability Engineering/Reliability Centered Maintenance) task.
- Coordinate with project management to align construction timelines with operational requirements.
- Ensure asset task delivery throughout the process.
- Maintain up to date metrics, status, and current activities
RCM and Metrology
- Plan and schedule RCM activities/deliverables for new assets to ensure they meet GMP standards.
- Create and update task that align with MPD schedules and feed into metrics status updates.
- Collaborate with RE/RCM/Metrology SME teams to ensure effective execution of planned work.
- Track and follow new instrument initial calibration delivery requirements and report in metrics
Communication and Coordination
- Interface with various stakeholders, including project managers, engineers, maintenance/metrology, and operations personnel.
- Provide updates on project status and any potential impacts on operations.
- Ensure all necessary documentation is complete and accessible for compliance audits.
- Develop relationships with key stakeholders and meet as necessary to receive updates
- Communicate with key stakeholders for approvals of completed documents and submittals
Qualifications
Education and Experience
- A bachelor's degree in engineering, project management, or a related field is preferred
- Experience in a pharmaceutical or regulated industry is essential, with a focus on construction and asset delivery.
Skills
- Proficiency in scheduling software or similar systems.
- Strong understanding of GMP regulations and compliance requirements.
- Excellent communication and organizational skills to manage multiple projects effectively.
Conclusion
The construction asset delivery planner/scheduler in a GMP pharmaceutical environment is vital for ensuring that new construction assets are delivered on time and completed in accordance with the asset deliverable requirements. This position requires a blend of technical knowledge, project management skills, and effective communication to support the overall operational goals of the organization.
Info batch - validation and commissioning project with the automation group
Drive Continuous improvement initiatives and systems across batch and continuous manufacturing
must have clean room gowning for ISO 7
Validation tech writing
OSI PI
"Extensive hands-on expertise with Rockwell/Allen-Bradley platforms (ControlLogix, CompactLogix), Ignition SCADA, and FactoryTalk systems, enabling real-time process monitoring, control, and data acquisition across batch and continuous manufacturing operations." was a bullet point from a resume he said to post
Description
The Third Party Management Specialist will oversee Third Party Quality
operations for the MA BioCampus, ensuring excellence in quality
standards and regulatory compliance across external partnerships. This
role requires leading Supplier Change Notification (SCN) processes,
managing third party quality event investigations, supporting quality
agreement programs including periodic reviews and documentation, and
collaborating cross-functionally with QC, Facilities, and
Manufacturing departments to resolve compliance issues. The ideal
candidate will have a Bachelor's degree or equivalent experience in
Supplier Quality, minimum 6 years of Quality/Operations experience in
a biotech/pharmaceutical cGMP manufacturing environment within an
FDA-regulated industry, proficiency in Veeva quality management
systems, and strong knowledge of global pharmaceutical regulations
(US, EU, Canada, Japan, Australia). This position reports to the Head
of Quality Third Party and requires the ability to gown and enter
manufacturing.