Senior CQV Engineer
Job in
Muncie, Delaware County, Indiana, 47302, 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
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×