Job Summary:
We are seeking a Sr. Validation & Compliance Engineer to support commissioning, qualification, and validation (CQV) activities for equipment, utilities, and facilities within a regulated pharmaceutical/biotech manufacturing environment. The role involves developing and executing IQ/OQ/PQ protocols, supporting process validation and technology transfer activities, ensuring compliance with FDA/EMA regulations, and collaborating cross-functionally to deliver compliant and inspection-ready systems. The ideal candidate will possess strong technical writing, problem-solving, and validation lifecycle management experience.
Roles & Responsibilities:
- Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities.
- Author, review, and approve qualification protocols, test scripts, deviation reports, and validation summary reports.
- Perform risk-based commissioning and qualification activities in alignment with FDA, EMA, cGMP, and internal quality standards.
- Coordinate with Engineering, Quality Assurance, Validation, Manufacturing, and Operations teams throughout the CQV lifecycle.
- Support technology transfer activities, process validation, and successful handover of validated systems to manufacturing.
- Participate in deviation investigations, root cause analysis, CAPA implementation, and continuous improvement initiatives.
- Ensure all validation activities are executed in compliance with GDP, data integrity, and regulatory expectations.
- Assist with change control assessments, periodic reviews, and maintenance of validated systems.
- Support inspection readiness activities and provide validation documentation during internal/external audits.
Education & Experience:
- Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.
- Minimum 5+ years of experience in commissioning, qualification, and validation (CQV) within pharmaceutical, biotech, or FDA-regulated industries.
- Hands-on experience with equipment qualification, utilities validation, and facility commissioning activities.
- Strong knowledge of cGMP, FDA, EMA, and industry validation standards.
- Proven experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
- Experience with deviation management, CAPA systems, and risk assessment methodologies.
- Excellent technical writing, communication, and cross-functional collaboration skills.
- Familiarity with process validation, technology transfer, and manufacturing support activities preferred.