CQV Engineer: GMP Qualification & Commissioning Specialist
Job in
City of Albany, Albany, Albany County, New York, 12201, USA
Listed on 2026-10-13
Listing for:
Katalyst-Healthcares-
Full Time
position Listed on 2026-10-13
Job specializations:
-
Engineering
Pharma Engineer, Quality Engineering, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Job Summary:
The CQV Engineer is responsible for supporting commissioning and qualification activities for pharmaceutical or biotechnology manufacturing facilities, equipment, utilities, and systems. The role ensures systems are properly commissioned, qualified, documented, and compliant with GMP, FDA, GAMP 5, and applicable regulatory requirements.
Key Responsibilities:
- Develop and execute Commissioning and Qualification (C&Q) documentation and activities.
- Prepare and execute URS, DQ, IQ, OQ, and PQ protocols.
- Support equipment, facility, utility, and process qualification.
- Review engineering/design documentation, specifications, and P&IDs.
- Develop and execute FAT/SAT activities with vendors and project teams.
- Perform field verification, commissioning, and qualification testing.
- Document test results, discrepancies, deviations, and corrective actions.
- Support risk assessments and qualification strategy development.
- Work with Engineering, Quality, Manufacturing, Automation, and Validation teams.
- Support deviation investigations, CAPA, and change control activities.
- Ensure qualification activities comply with GMP, FDA, GAMP 5, and company procedures.
- Coordinate with vendors and contractors during equipment installation, startup, and qualification.
- Prepare final qualification reports and support system release.
- Bachelor's degree in Engineering, Life Sciences, or related technical field.
- Typically 3–7+ years of CQV/Validation experience in pharmaceutical, biotechnology, or regulated manufacturing.
- Experience with IQ/OQ/PQ, FAT/SAT, URS, DQ.
- Strong GMP and regulatory knowledge.
- Experience with manufacturing equipment, utilities, facilities, or process systems.
- Knowledge of GAMP 5, FDA, 21 CFR Part 11 and data integrity principles.
- Experience with deviations, CAPA, change control, and risk assessments.
- Strong technical writing and documentation skills.
- Ability to work independently and collaborate with cross-functional teams.
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:
×