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

Location: Maryland

Duration: 6 Months

• Overview:
  • Respond to on-demand troubleshooting requests from Manufacturing Sciences pertaining to the clients OSI PI and Kepware systems. Escalate outstanding issues to ES&T Automation and Manufacturing area management
  • Background in GMP / 21CFR Part 211 Regulations
• Specific Skills:
  • OSI PI Tools for tag creation, modifications, troubleshooting, and trend visualization.
  • OSI PI point configuration investigation
  • Kepware Clients
  • Segregated network infrastructure
  • vCenter vSphere
  • Windows Virtual Machine Admin Tools

Please have candidates with 3-15 years of experience

The Client is dedicated to making products that save lives and improve patient health worldwide. As a Senior Automation Engineer, you will design, implement, and maintain automated systems in a cGMP environment to enhance manufacturing efficiency and reliability, while collaborating with various teams to ensure compliance and operational excellence.

Understanding of Data Historian and Production Lines -Historian Systems

Vast Understanding of Automation Network - network side of automation

Design, develop, and implement automated systems, including software, hardware, and processes

Analyze existing systems, identify areas for automation, and create solutions that meet specific needs

Configure and/or manage site-level automation systems (e.g., serialization, data historian, reporting, industrial networking)

Lead the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities, including authoring and/or reviewing IQ/OQ/PQ protocols, test execution, and authoring summary reports

Support the development of site automation standardization and/or technology master plans

Write scripts and code to automate tasks, processes, and workflows using various programming languages

Test and optimize automated systems to ensure they function correctly and efficiently

Identify and resolve issues and continuously improve system performance

Implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products

Troubleshoot and resolve issues with automated systems, ensuring they operate smoothly

Diagnose problems, implement fixes, and perform maintenance tasks

Support maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, execution of automation-related PMs (e.g., backup/restore), and support of out-of-tolerance investigations related to instrument calibrations

Collaborate with other engineers, technicians, and stakeholders to develop and implement automation solutions

Effectively communicate technical information and ensure project success

Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls, and CAPAs through participation on cross-functional teams

Participate in plant engineering, maintenance, and calibration activities as needed

Required

BS in engineering/related degree or equivalent experience

8+ years of related experience; or 6 years with a master's degree, or 3 years with a PhD

Experience with a variety of PLCs, HMI hardware, and industrial sensors and applications

Controls design experience

General electrical design knowledge

Working knowledge of cGMP, GAMP5, and regulatory requirements

Technical writing experience such as: SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal

Preferred

Minimum of 8 years of previous work experience in a related field

Experience working with nasal spray products and devices or related drug-delivery devices

Industrial networking and server management

Experience with site-level automation systems such as: Serialization: Antares, Tracelink, Data historian: Aveva OSI PI, Reporting systems: OSI PI, MS Report Builder, SQL Development, Kepware, Matrikon, AB Factory Talk, Automated Visual Inspection

Maintenance Package Development (MPD) Lead

Location: Indiana

Duration: Jan 2026 – Dec 2027 (24 months), extendable to 36 months

Project Background: 

The objective for the Client Program is to deliver a new highly automated and state-of-the-art clinical trial manufacturing facility. The campus will have buildings for classic synthetic chemistry and monoclonal antibody production as well as areas for newer modalities including conjugates, peptides, and oligonucleotides. This campus will be comprised of multiple different buildings which include:

·     Lab/admin building

·     Warehouse

·     Central utilities building (CUB)

·     Tank farm and central corridor

·     Small Molecule building

·     Biologics building

·     Hybrid building

Maintenance Package Development (MPD) Program Objective: 

The primary goal of the MPD program is to ensure the timely development and      delivery of accurate, complete maintenance packages to Site Engineering, Maintenance, and Process Owners. The scope of MPD includes identification and entry of data needed to complete the population for all CMMS entries including Locations, Assets, Job Plans, Preventive Maintenance (PM)’s and Spare Parts. The program is comprised of these typical activities; however, this is not an exhaustive list:

·     Reconciliation of tag data on drawings, compared to Project Information Management (PIM) data.

·     Identify information required for MPD development to support project information management data, drawing, and document requirements

·     Define maintenance analysis, data, and document development activities and requirements for delivery of MPD packages

·     Define tools and templates that will be used for the delivery of the MPD information

·     Identify logical maintenance development milestones and work with P6 / schedule owner for project integration

·     Describe owner review and approval of maintenance packages

·     Identify and provide MPD status, tracking, and metric reporting requirements

·     Identify development and management strategies for package delivery

·     Ensure that data and document delivery timing is integrated with the owner’s Commissioning & qualification (C&Q) activities, i.e., calibrations.

·     Development of Location data load sheets 

·     Development of Asset data load sheets 

·     Development of Maintenance and Calibration Job Plans in GMARS 

·     Development of calibration data sheets in GMARs

·     Development of PM data load sheets 

·     Development of recommended stocking strategy to reliability engineers for stocking strategy

Role Responsibilities:

·     Oversee/Own the coordination, planning, scheduling, development, and execution of all MPD activities.

·     Utilize The Clientand contracted resources to achieve overall success

·     Ensure timely deliverable and milestones

·     Establish metrics and provide real-time assessments of deliverables to GFD PIM/Verification/MPD Lead and Project Management

·     Own communication plan and facilitation between cross discipline teams (PIM, C&Q, Maintenance, and Ops readiness) relative to roles and responsibilities, deliverables, and timing.

·     Seek alignment of scope with cross functional groups (PIM, site, project)

·     Ensure alignment with Global and Site procedures for MPD activities

·     Assist in the development, review, and approval of site-specific MPD strategy documents and procedures

Role Requirements:

·     BS Engineering (or equivalent experience).

·     10+ years of project management, engineering, maintenance or operations

·     Demonstrated leadership and people management skills.

·     Ability to lead of group of The Client employees as well as contractors.

·     Knowledge of GMP’s, regulatory requirements, and maintenance

·     Knowledge and working understanding of GMARs

·     Good written and verbal communication skills with both technical and non-technical staff.

·     Knowledge of The Client internal procedures and policies and how they apply to the development and management of maintenance packages and activities

·     Working Knowledge of Reliability Centered Maintenance (RCM) and how RCM drives maintenance tasks, intervals, etc.

Travel: 

·     No project travel time is anticipated; however, an Indiana presence is strongly preferred with a minimum of ~50% on site time.

Additional Information:

·     40 hours per work week

·     An hourly rate all-inclusive of any travel, relocation, or temporary housing expenses.

Quality System Lead. 

Under limited supervision:

·      Quality Lead for the business working with the Windchill PLM team to map out data migration for The Client Inc procedures, work instructions, parts, specification, records, etc (all quality system document types) into new system container

·      This includes overall change management process development and implementation for The Client Inc.

·      Document Control Management

·      Develops full knowledge of the The Client quality system and plans transition out of the The Client quality system into a stand-alone/hybrid quality system across Neurovascular business.

·      Lead quality system harmonization and improvement efforts, including developing quality plans/project plans and maintaining project schedules. 

·      Monitors overall quality system project, identifies issues, recommends and implements appropriate actions

·      Ensures any Quality System changes are in accordance with requirements of FDA 21 CFR Part 820, ISO13485:2016, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, , Australia TGA and other applicable regulatory standards considering the countries/regions products are marketed.

Requirements:

·      Comprehensive knowledge of ISO 13485:2016, FDA QSMR.

·      Change Management Experience

_________________________________________________________________________________________________

FROM QUALIFICATION CALL:

Key experience needed for the role is:

1) Change Mgmt exp, documentation explained and justified

2) Comprehensive exp in 13485 as well as QSMR.

Pluses would be having been a Quality Mgmt representative or having had past audit exp. They are using ETQ but she said exp with this system is not necessary.

Candidate should know how to separate the reqs from what The Client needs and what THE CLIENT was doing then maintaining compliance

They have a sister company in Ireland- she wants to harmonize some things in the QS- they'll look at CNV and Niravi... can they harmonize this procedure while doing the transition with t

Previous Client experience is ideal.

Management Rep is ideal.

Have to make sure they understand it's an execution role.... not looking for leader to tell people how to do things well or better... they need to understand design control to assess procedures.... but she's not going to change design controls.

Remote (on site every 4-8 weeks and a while and orientation)

12 months + extensions

Number of positions: 3

Client is looking for someone (not programmer or code writer) with Delta V writing executing protocols create documents and test scripts from blank templates. Will also take CQV with experience with writing documents that has experience with Delta V. Client can interview next week.

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.

Role Overview

We are seeking a motivated Systems Engineer to support the development and optimization of Roche’s next-generation sequencing (NGS) platform. This is a hands-on, lab-focused role within the Systems Development Group, contributing to feasibility, verification, and integration of end-to-end sequencing workflows.

Key Responsibilities

Perform sample prep, library prep, and sequencing experiments in a structured R&D environment.

Execute and document verification and validation test cases for sequencing workflows.

Analyze experimental data, interpret results, and contribute to protocol development.

Support troubleshooting of instrument and reagent-related issues.

Maintain high-quality laboratory documentation and SOPs.

Collaborate with multidisciplinary teams (chemistry, hardware, software).

Participate in customer support activities as needed after initial training.

Required Qualifications

Hands-on PCR experience required (must be able to explain principles, controls, and troubleshooting).

Prior laboratory experience with nucleic acid handling and contamination control.

Strong written and oral communication skills.

Preferred Qualifications

Hands-on experience with NGS workflows (library prep, sequencing, data review).

Familiarity with Illumina or similar sequencing platforms.

Experience with MATLAB, Python, or similar tools for data analysis.

Background in assay development, troubleshooting, or prototype instrumentation.

Knowledge of statistical analysis (DOE, ANOVA, SPC) is a plus.

Desired Attributes

High energy, curious, and self-motivated.

Team-oriented with strong problem-solving skills.

Comfortable working in a fast-paced, iterative R&D environment.

The Principal Mechanical Engineer will play a vital role in driving innovation for our next-generation instrumentation. We are looking for someone that exhibits a high degree of motivation, independence, and resourcefulness to help us develop solutions to novel DNA Sequencing and automation challenges in a fast-paced and collaborative environment.

Core Responsibilities

You will lead the end-to-end mechanical design and development of mechanical sub-systems including electro-mechanical, pneumatic, fluidic, and thermal components.

You will collaborate with engineers from other disciplines (electrical, consumables, materials) to define and manage all critical technical interfaces for your module.

You will develop novel mechanisms for automated reagent and flow cell loading, clamping, and sealing, ensuring reliability over repeated use.

You will architect and design thermal control systems, including the specification and integration of heating/cooling elements, sensors, condensation control, and heat management.

You will partner with internal and external simulation experts to guide and validate CFD, thermal, and optical models, using empirical data to refine designs.

You will serve as the primary technical expert for your sub-system during integration, verification, and troubleshooting activities, working directly with the Systems Integration team.

You will lead cross-functional design reviews, driving alignment and resolving technical trade-offs between mechanical design, consumables, materials, and assay requirements.

You will drive the technical execution for sub-systems, manage timelines for your design deliverables, and contribute to the overall project plan.

You will create and maintain all design documentation for your sub-systems, including detailed CAD models, drawings, and specifications.

You will contribute to the technical strategy for the future integrated system, providing data-driven recommendations on architecture and technology choices based on your sub-system's performance.

You will present technical progress, data, and design trade-offs to the broader project team and key stakeholders, clearly articulating the rationale and impact of engineering decisions.

A cover letter is required for this application. Please outline your relevant experience and explain why you are interested in this role and our company.

Who You Are:

(Required)

You have a PhD in Mechanical Engineering, Bioengineering, or a related discipline with at least 5 years of relevant industry experience; or a Master's degree in Mechanical Engineering, Bioengineering, or a related discipline with at least 10 years of relevant industry experience; or a Bachelor's degree in Mechanical Engineering, Bioengineering, or a related discipline with at least 10 years+ of relevant industry experience.

You have demonstrated deep, hands-on expertise in the design, development, and testing of complex mechanical, electro-mechanical, and pneumatic systems, preferably for life science or diagnostic instrumentation.

You have demonstrated hands-on expertise in thermal management and the design of precision temperature control systems.

You have experience developing fluidics systems and their interfaces including pumps, valves, tubing, sensors, and material selection.

You possess strong proficiency in 3D CAD software (e.g., SolidWorks) for detailed design and the creation of manufacturing drawings.

You have expertise designing components for a variety of manufacturing processes (e.g., machining, injection molding, 3D printing).

You are a creative and resourceful problem-solver, with the ability to troubleshoot complex issues at the interface of hardware, software, and chemistry.

You are proficient with common machine shop tools, as well as test and measurement equipment; proficient with rapid prototyping technology such as 3D printers, laser cutters, CNC mills/lathes, etc; and

You have a demonstrated level of proficiency with Python, LabVIEW, or similar tools for device control and data acquisition.

Preferred:

You have demonstrated the ability to lead technical projects and mentor junior engineers, providing clear guidance and delegating tasks to achieve project goals.

You have experience using simulation tools (CFD, FEA) to guide design decisions.

You have previously worked on the development of next-generation sequencing (NGS) or other genomics instrumentation.

You have experience working in a regulated product development environment

You have demonstrated strong interpersonal and communication skills with the ability to communicate technical knowledge in a clear and understandable manner, especially to non-experts; you excel at problem-solving skills and the ability to work under ambiguous situations.

You have excellent organizational skills, including the ability to efficiently evaluate, prioritize and handle multiple changing projects and priorities; you complete work in a timely, accurate and thorough manner.