Lead Validation Engineer

Position : Lead Validation Engineer

Location : New Jersey, United States

Experience : 5+ years

Contract : 12+ months

About the Role :

We are looking for a highly skilled and detail-oriented Lead Validation Engineer to oversee commissioning, qualification, and validation activities for process equipment and laboratory systems in a GMP-regulated pharmaceutical environment. This role ensures that all systems are designed, installed, tested, and maintained in compliance with regulatory requirements and internal quality standards.

Key Responsibilities :

Lead CQV activities for process equipment and laboratory instruments / systems, ensuring compliance with cGMP, FDA, EMA, and ICH guidelines.

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

Coordinate commissioning activities, including FAT and SAT, and facilitate smooth transitions to qualification.

Conduct risk assessments to define the scope of qualification, including impact and criticality analyses.

Collaborate with Engineering, Quality Assurance, Manufacturing, and Validation teams for project alignment.

Support laboratory system validation, including analytical instruments, data integrity, and computerized system validation (CSV).

Troubleshoot and resolve CQV-related issues and deviations.

Participate in regulatory audits and inspections, providing SME-level support for equipment and lab validation topics.

Maintain knowledge of validation regulations, industry best practices, and emerging technologies.

Qualifications :

Bachelor's degree in Engineering, Life Sciences, or a related technical field (Master's preferred).

Minimum 5 years of experience in CQV within the pharmaceutical or biotech industry, with expertise in process equipment and lab systems.

Strong understanding of GMP, GAMP 5, 21 CFR Part 11, and other regulatory 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 (WFI, clean steam, HVAC) and process support systems.

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

Experience with greenfield or brownfield facility start-up projects.