Principal Fill Finish Engineer – OPTIMA Filling Lines
Job in
Lowell, Middlesex County, Massachusetts, 01856, USA
Listed on 2026-05-31
Listing for:
i-Pharm GxP
Full Time
position Listed on 2026-05-31
Job specializations:
-
Engineering
Manufacturing Engineer, Validation Engineer, Quality Engineering, Operations Engineer
Job Description & How to Apply Below
Principal Fill Finish Engineer – OPTIMA Filling Lines
Massachusetts | Onsite
We are currently supporting a leading pharmaceutical manufacturer in Massachusetts that is seeking a Principal Fill Finish Engineer to support a major aseptic manufacturing project.
This individual will play a key role in taking a new fill finish line from commissioning through media fills and final handoff to manufacturing operations.
Key Responsibilities- Lead technical oversight of fill finish line activities from commissioning through operational readiness
- Support commissioning and qualification execution activities
- Drive media fill readiness, execution, and troubleshooting
- Coordinate with Engineering, CQV, Manufacturing, Automation, and Quality teams
- Support line start-up, optimization, and operator handoff
- Ensure GMP compliance and alignment with project timelines
- Provide technical expertise on OPTIMA filling systems throughout the project lifecycle
- 8+ years of experience within pharmaceutical or biotech manufacturing environments
- Strong background supporting aseptic fill finish projects
- Direct experience with OPTIMA filling lines is required
- H6-H10 OPTIMA line experience highly preferred
- SV125 line experience will also be considered
- Experience supporting commissioning, qualification, media fills, and operational handoff
- Strong understanding of GMP manufacturing and aseptic processing environments
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