Lead Aseptic Fill/Finish Engineer
This role will serve as a technical co-lead for the aseptic fill/finish scope, partnering directly with project leadership to drive design, implementation, and startup of critical systems. This is a hands-on engineering leadership role, requiring deep expertise in fill/finish technologies and full lifecycle project delivery.
Core Responsibilities
- Act as co-lead for fill/finish systems, owning technical delivery from design through startup and commercial readiness
- Lead equipment selection, specification (URS), and vendor engagement for aseptic processing systems
- Drive system integration across fill/finish, utilities, automation, and facility design
- Oversee design reviews, FAT/SAT, commissioning, and startup execution
- Ensure alignment with Contamination Control Strategy (CCS) and support risk assessments (FMEA, HACCP, etc.)
- Partner with cross-functional teams (Process, CQV, Automation, Facilities, Quality) to ensure seamless execution
- Troubleshoot performance, sterility, and integration issues during startup and operational readiness
Required Technical Expertise
Candidates must have expert-level, hands-on engineering experience in the design and implementation of:
- Nested syringe isolator fill lines
- E-beam sterilization systems
- Stopper processing systems
- Single-use systems (SUS) integration
- PUPSIT / filter integrity testing systems
- Parts washers and parts autoclaves
- CCIT (Container Closure Integrity Testing)
- Semi-automated inspection systems
Additionally:
- Strong understanding of aseptic processing environments, facility finishes, and cleanroom design
- Deep experience with CCS development and execution
- Proven ability to lead risk assessments and contamination control strategies
Experience Requirements
- 10+ years of experience in aseptic fill/finish engineering within pharma/biotech
- Demonstrated experience leading design and implementation, not just supporting validation or operations
- Proven track record delivering fill/finish systems through full project lifecycle (design → build → startup)
- Experience working owner-side or with major EPCs/engineering firms
- Strong leadership presence with the ability to operate as a technical authority and co-lead
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