CQV Engineer
Listed on 2026-09-22
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Engineering
Validation Engineer, Pharma Engineer, Quality Engineering
We are seeking a motivated CQV Engineer with 0-3 years of experience to support Commissioning, Qualification, and Validation (CQV) activities within pharmaceutical, biotechnology, and other regulated life-sciences manufacturing environments. The role will provide hands-on exposure to equipment, facility, utility, and process qualification, including IQ/OQ/PQ execution, commissioning activities, system walkdowns, protocol development, and qualification documentation.
The CQV Engineer will work closely with Engineering, Validation, Quality, Manufacturing, Automation, and Project teams to ensure systems and equipment are properly commissioned, qualified, documented, and compliant with applicable cGMP requirements. This position is well suited for an early-career engineer looking to build a strong foundation in CQV, validation, commissioning, and pharmaceutical engineering.
Key Responsibilities- Support Commissioning, Qualification, and Validation activities for pharmaceutical and biotech facilities.
- Assist with development and execution of IQ, OQ, and PQ protocols.
- Support preparation and review of URS, FRS, design specifications, test scripts, and qualification documentation.
- Participate in equipment and system walkdowns, field verification, and punch-list activities.
- Support qualification of process equipment, utilities, clean utilities, and manufacturing systems.
- Assist with commissioning, startup, functional testing, and system turnover activities.
- Support deviation, discrepancy, change control, and CAPA activities.
- Review engineering, vendor, and technical documentation for qualification readiness.
- Maintain accurate documentation in accordance with cGMP and data-integrity requirements.
- Collaborate with Engineering, Quality, Manufacturing, Validation, and Project teams.
- Support execution of qualification activities according to project schedules and established procedures.
- Bachelor's degree in Chemical, Mechanical, Electrical, Biomedical, Pharmaceutical, or related Engineering.
- 0-3 years of experience in CQV, validation, commissioning, manufacturing, engineering, or a related field.
- Basic understanding of cGMP and regulated manufacturing environments.
- Understanding of IQ/OQ/PQ and qualification concepts.
- Strong documentation, communication, analytical, and problem-solving skills.
- Ability to work in a hands-on/site-based environment.
- Exposure to GAMP 5, 21 CFR Part 11, EU GMP, or data-integrity principles.
- Familiarity with URS/FRS, risk assessments, traceability matrices, and validation protocols.
- Exposure to pharmaceutical equipment such as bioreactors, vessels, pumps, CIP/SIP systems, filtration systems, chromatography systems, and process skids.
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