[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.
This is an urgent Visual Inspection need supporting finished product (vials and syringes).
Role overview:
• Visual Inspection contractors (1–2 openings)
• Finished product defects – vials & syringes
• Must be absolutely certified in Visual Inspection (vials/syringes specifically);
• Will help oversee inspection activities and recertify new inspectors
• Shift work – 24/5 flexible coverage
• Shortage of both people and kits – they need true go-getters
• Keep inspection kits 100% utilized
• Quickly growing site (~500 people)
Nice to have:
• Some experience writing SOPs from scratch
• Leadership mentality / able to help stabilize operations
Important constraints:
• NO NEO – candidates must already be fully certified and ready to start
• They are NOT paying for week-long NEO/onboarding
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