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Equipment CQV Engineer
Job in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-08-29
Listing for:
Stark Pharma Solutions Inc
Full Time
position Listed on 2026-08-29
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Pharmaceutical
Pharmaceutical Manufacturing, Pharma Engineer, Quality Engineering, Pharmaceutical Science/ Research
Job Description & How to Apply Below
Role
Seeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. The role focuses on hands‑on execution of equipment commissioning and qualification activities across manufacturing, laboratory, and support of equipment in a regulated GMP environment.
RoleSeeking experienced Equipment CQV Engineers to support an onsite GMP equipment qualification program at a biopharmaceutical manufacturing facility. The role focuses on hands‑on execution of equipment commissioning and qualification activities across manufacturing, laboratory, and support of equipment in a regulated GMP environment.
Key Responsibilities- Review and execute established equipment qualification protocols (IQ/OQ).
- Document test results and identify/resolve execution issues.
- Support equipment readiness for manufacturing and engineering activities.
- Qualify various manufacturing, laboratory, and support equipment.
- Partner with Engineering, Validation, Manufacturing, Quality, and equipment vendors.
- Work independently, moving quickly through multiple equipment packages.
- 5 10 years of CQV, equipment validation, or equipment qualification experience.
- Strong hands‑on experience executing IQ/OQ and other equipment qualification protocols.
- Pharmaceutical, biotechnology, biopharmaceutical, cell therapy, or other GMP‑regulated manufacturing experience.
- Experience qualifying for manufacturing and/or laboratory equipment.
- Ability to review protocols, execute testing, document results, and address discrepancies/deviations.
- Understanding GMP documentation and good documentation practices.
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