PM Group ยท 2 weeks ago
Sr Process Engineer - Fill / Finish
Somerset, NJ
Full-time
Onsite
Senior Level
7+ years expPM Group is seeking a Senior Process Engineer to join their Outsourced Technical Services group, focusing on capital delivery programs for pharmaceutical and biotechnology clients. The role involves end-to-end ownership of GMP process systems, providing design leadership and technical governance across various project phases and ensuring compliance with safety and operability standards.
Architecture
Responsibilities
Serve as Process Work Package Owner for GMP manufacturing process systems on capital projects
Lead process design activities across project phases, including conceptual design, basic design, detailed design, and design for CQV readiness
Develop and review process flow diagrams (PFDs), piping and instrumentation diagrams (P&IDs), equipment specifications, datasheets, and design narratives
Ensure process designs meet GMP, safety, operability, maintainability, and lifecycle requirements
Act as technical lead for assigned process systems, coordinating closely with Facilities, MS&T, Automation, Validation, CQV, and Equipment End Users
Drive execution of medium to large-scale process work packages with complex scope, aggressive schedules, and high compliance expectations
Provide technical oversight during equipment procurement, FAT/SAT support, construction, installation, and startup activities
Support design change management and field-driven modifications during construction and commissioning
Own the process scope through CQV, ensuring design intent is effectively translated into commissioning and qualification activities
Partner with CQV teams to support commissioning strategies, system boundaries, risk assessments, and qualification documentation
Ensure smooth engineering turnover to CQV and operations, maintaining complete and compliant documentation packages
Support start-up and operational readiness, including system troubleshooting and performance optimization
Provide Subject Matter Expertise (SME) for GMP process equipment, including but not limited to: Fill / Finish Equipment
Lead structured root cause investigations for equipment or process issues, independently driving resolution
Own or support Change Controls, Deviations, and CAPAs related to process systems
Contribute to preventative maintenance strategies and continuous improvement initiatives
Produce and review high-quality technical documentation in accordance with client quality systems and PM Group standards
Maintain Engineering Turnover Packages (ETOPs), including specifications, component lists, vendor documentation, drawings, and manuals
Ensure documentation supports both regulatory compliance and operational sustainability
Qualification
Required
Bachelor's degree in Chemical Engineering or Mechanical Engineering (or equivalent)
7+ years of relevant experience in GMP process engineering within pharmaceutical or biotechnology environments
Demonstrated experience acting as a process system owner or work package owner on capital projects
Strong background in process design, equipment specification, and lifecycle project delivery
Experience supporting projects through CQV and operational handover
Company
PM Group
PM Group is an international project delivery firm providing professional services in architecture, engineering and construction.
1001-5000 employees
H1B Sponsorship
PM Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (3)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Sam B.
CEO
Recent News
Irish Examiner
2025-09-13
2025-09-12
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