Sr. Fill Finish Process Engineer
at Synerg
San Diego, California, United States, senior, 7+ years
posted 19 Feb 2026
- Isolators
- Capping
- FDA
- Inspection processes
- Autoclaves
- APR
- Depyrogenation tunnels
- SAT
- CPV
- CAPA
- Aseptic manufacturing
- CIP/SIP systems
- P&ID
- Formulation
- Sterile filtration
- EMA
- Annex 1
- RABS
- Lyophilization
- GMP
- Inspection machines
- Commissioning
- ICH
- KNEAT
- PQR
- Qualification
- SOP
- FAT
- Aseptic filling
- Sterile filtration skids
- Formulation vessels
About the role
Posted: 2026-02-19
Travel to client sites may be required up to 100% based on project phase and client needs.
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.
We are actively seeking qualified candidates to join our talent pipeline for future client engagements.
What you would do
(This list is not exhaustive and may be adjusted as needed.)
- Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
- Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
- Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
- Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
- Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
- Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
- Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
- Support continuous improvement and process optimization initiatives.
- Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
- Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
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