CQV Engineer

Job Description CQV LEAD POSITION

POSITION:

We are seeking an experienced and detail-oriented CQV Lead to oversee and execute commissioning, qualification, and validation activities for process equipment and laboratory systems within a GMP-regulated pharmaceutical environment. This role is critical in ensuring that all equipment and lab systems are designed, installed, tested, and maintained according to regulatory requirements and internal quality standards.

RESPONSIBILITIES:

· Lead CQV efforts for new and existing process equipment and lab instruments/systems, ensuring compliance with cGMP, FDA, EMA, and ICH guidelines.

· Develop and review CQV documentation including URS, DQ, IQ, OQ, PQ protocols and reports.

· Coordinate and oversee commissioning activities, including FAT and SAT, and ensure proper transition to qualification.

· Perform risk assessments (e.g., impact assessments, component criticality analysis) to define qualification scope.

· Collaborate with Engineering, Quality Assurance, Manufacturing, and Validation teams to ensure project alignment.

· Support lab system validation including analytical instruments, data integrity, and computerized system validation (CSV), where applicable.

· Troubleshoot and resolve CQV-related issues and deviations.

· Participate in regulatory audits and inspections; provide SME-level support on equipment and lab validation topics.

· Maintain up-to-date knowledge of validation regulations, industry best practices, and technological advancements.

QUALIFICATIONS:

· Bachelors degree in Engineering, Life Sciences, or related technical discipline (Masters preferred).

· 5+ years of experience in CQV within the pharmaceutical/biotech industry, with a strong focus on process equipment and lab systems.

· Solid understanding of GMP regulations, GAMP 5, 21 CFR Part 11, and other relevant guidelines.

· Proven experience in writing and executing qualification protocols.

· Familiarity with analytical lab equipment (HPLCs, GCs, incubators, etc.) and CSV principles.

· Excellent project management, organizational, and communication skills.

· Ability to work independently and manage multiple priorities in a fast-paced environment.

PREFERRED EXPERIENCE:

· Experience with clean utilities (e.g., WFI, clean steam, HVAC) and process support systems.

· Knowledge of MES, LIMS, or other laboratory management systems.

· Previous experience in greenfield or brownfield facility start-up projects.