Project Engineer, Process Engineer
Listed on 2026-07-18
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Engineering
Process Engineer, Quality Engineering, Manufacturing Engineer
Mechanical / Process / Chemical Engineer 12-Month Contract | Onsite | W2 Only
We are supporting a major GMP biologics manufacturing expansion and are seeking an experienced Mechanical, Process, or Chemical Engineer to support the design and early execution phases of a large-scale capital project.
The successful candidate will act as an Owner's Representative, providing technical oversight of engineering deliverables, challenging design decisions where appropriate, and ensuring systems are robust, maintainable, operationally fit for purpose, and aligned with project requirements.
This role requires someone with a strong engineering mindset who is comfortable influencing technical decisions while working closely with EPCM contractors, OEMs, Automation, CQV, Manufacturing, Operations, and Quality teams.
Key Responsibilities- Review and challenge engineering designs throughout the project lifecycle.
- Ensure equipment and system designs meet operational, maintenance, GMP, and project requirements.
- Review P&IDs, URSs, engineering specifications, vendor documentation, and equipment packages.
- Provide technical oversight during Basic Design, Detailed Design, Procurement, FAT, Commissioning, and Startup.
- Work closely with cross-functional stakeholders to resolve technical issues and drive engineering decisions.
- Support design reviews, risk assessments, and vendor interactions.
- Act as the owner's technical representative throughout project execution.
- 7-10+ years' experience supporting pharmaceutical or biopharmaceutical capital projects.
- Experience supporting large-scale biologics manufacturing facilities.
- Proven experience supporting projects from Basic Design through Detailed Design, Procurement, FAT, Commissioning, and Startup.
- Previous experience as an Owner's Representative, Equipment/System Owner, or Lead Mechanical/Process Engineer.
- Strong understanding of P&IDs, URSs, engineering specifications, equipment packages, and vendor documentation.
- Experience reviewing EPCM contractor deliverables and providing technical challenge.
- Excellent communication and stakeholder management skills.
- Willingness to work onsite as project activities increase.
Experience with one or more of the following process systems:
- Chromatography systems (Anion Exchange, Cation Exchange, Immunoaffinity, or SMB preferred)
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