Senior CQV Engineer
Job in
South Bend, St. Joseph County, Indiana, 46601, USA
Listed on 2026-11-01
Listing for:
i-Pharm GxP
Per diem
position Listed on 2026-11-01
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering, Pharma Engineer
Job Description & How to Apply Below
Senior CQV Engineer, Peptide Manufacturing | Lebanon, Indiana
We're looking for an experienced Senior CQV Engineer to join a major pharmaceutical capital program in Lebanon, Indiana. You'll sit within the process team, delivering commissioning, qualification and validation of peptide API manufacturing equipment from construction through to handover.
This is a hands-on, field-based role for someone who knows peptide processes, is comfortable working alongside construction and engineering, and can contribute from day one.
- Initial 12-month contract, with extensions anticipated
- Fully onsite in Lebanon, Indiana, five days a week
What you'll be doing:
- Commissioning and qualifying peptide manufacturing equipment, including solid-phase peptide synthesis (SPPS) reactors, cleavage and precipitation systems, preparative HPLC and chromatography skids, lyophilizers and solvent handling and recovery systems.
- Supporting the supporting utilities, including nitrogen, process chillers, purified water, CIP and containment systems.
- Carrying out P&, loop checks, component verification and functional testing in the field.
- Developing and executing IQ/OQ/PQ protocols, ideally in Kneat, and supporting FAT/SAT.
- Working through punch lists, deviations and troubleshooting to keep systems moving.
- Building turnover packages and traceability matrices for handover.
- Working with Construction, Engineering, Automation, Validation and QA to deliver systems to GMP standards.
What we're looking for:
- 5+ years of hands-on C&Q experience in pharmaceutical or biotech GMP facilities.
- Direct experience with peptide or synthetic API manufacturing equipment.
- Protocol development and execution experience, ideally in Kneat or a similar electronic validation system.
- A good understanding of cGMP, ASTM E2500 and risk-based C&Q.
- Experience with solvent-handling or explosion-proof (ATEX/Class I Div
1) environments is a strong plus. - Greenfield or facility expansion experience is a strong plus. Exposure to DeltaV or other DCS platforms-??
- A Bachelor's degree in Engineering, Chemistry, Life Sciences or a related technical field.
- Availability for overtime and occasional weekend work when the schedule requires it.
Position Requirements
10+ Years
work experience
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