Senior Process Engineer - Drug Product
Listed on 2026-10-14
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering -
Manufacturing / Production
Validation Engineer, Pharmaceutical Manufacturing, Quality Engineering
A leading biopharmaceutical manufacturer is seeking a Senior Lead/ Principal Process Engineer - Aseptic Drug Product Compounding to provide technical leadership for the design, delivery, commissioning, qualification, and start-up of a new state-of-the-art biologics manufacturing facility. The role will serve as the Subject Matter Expert (SME) for aseptic drug product compounding systems, including single-use technologies, stainless steel processing equipment, mixing, filtration, and cleaning/sterilisation systems.
Key Responsibilities- Lead the design and implementation of aseptic drug product compounding systems and suites.
- Develop engineering documentation including URS, P&IDs, PFDs, technical specifications, and equipment data sheets.
- Provide technical leadership for single-use mixers, stainless steel vessels, COP/SOP systems, filtration, and associated processing equipment.
- Manage vendor selection, equipment design reviews, and project execution activities.
- Lead FAT, SAT, Commissioning & Qualification (C&Q), and operational start-up activities.
- Partner closely with Manufacturing, Quality, MSAT, Facilities, Procurement, Engineering, and EHS teams to ensure successful project delivery.
- Drive technical problem solving, compliance, and continuous improvement initiatives.
- Bachelor's Degree in Engineering (Chemical Engineering preferred); advanced degree advantageous.
- 10+ years' experience in aseptic drug product compounding within a biotherapeutics cGMP manufacturing environment.
- Hands-on expertise with:
- Single-use technologies and mixers
- Stainless steel tank design
- Cleaning and sterilisation systems
- Mixing and filtration operations
- Proven experience leading capital projects, commissioning and qualification activities, and facility start-ups.
- Strong knowledge of cGMP requirements, process engineering, and aseptic manufacturing operations.
- Experience leading large-scale aseptic bio therapeutic compounding projects valued between $30M-$50M.
- Greenfield or brownfield GMP facility start-up experience.
- Expertise delivering projects from conceptual design through commissioning and operational readiness.
The successful candidate will initially be based in Conshohocken, Pennsylvania
, supporting the engineering and project execution phase. Following the first year, the role will transition to Wilson, North Carolina
, supporting site commissioning, qualification, and commercial operations
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