Validation Engineer

Job Description: The Senior CQV Engineer is responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities with a strong focus on CIP (Clean-In-Place) systems supporting Drug Substance Manufacturing. This role will serve as a technical subject matter expert for CIP system qualification and cleaning validation, ensuring compliance with GMP, regulatory, and internal quality standards. The ideal candidate brings hands-on experience in CIP system design review, qualification execution, and cleaning validation strategy, and can work independently in a fast-paced manufacturing environment while collaborating cross-functionally with Engineering, Manufacturing, Quality, and Automation teams. Senior CQV Engineer Responsibilities: CQV & Validation Execution: Lead and execute commissioning, qualification, and validation activities for CIP systems supporting Drug Substance manufacturing operations. uthor, review, and execute IQ, OQ, and PQ protocols for CIP equipment and associated utilities. Perform cleaning validation activities for CIP systems, including development of validation strategies, protocols, sampling plans, and final reports. Ensure CIP systems meet regulatory expectations for cleanability, reproducibility, and worst-case conditions. CIP & Cleaning Validation: ct as the SME for CIP systems, including spray devices, flow paths, cycle development, and acceptance criteria. Support CIP cycle development and optimization in collaboration with Engineering and Manufacturing. Perform risk assessments (e.g., FMEA, HACCP) to define validation scope and acceptance criteria. Support residue, bioburden, and TOC sampling strategies as part of cleaning validation. Drug Substance Manufacturing Support: Support Drug Substance manufacturing equipment and processes, ensuring validation activities align with process requirements and regulatory expectations. Collaborate with Process Engineering and Manufacturing to ensure validated cleaning processes support operational efficiency and compliance. Provide validation support during tech transfers, process changes, and new equipment installations. Compliance & Documentation: Ensure all CQV and cleaning validation documentation complies with GMP, FDA, EMA, and ICH requirements. Participate in deviation investigations, CAPAs, and change controls related to CIP systems and cleaning validation. Support internal and external audits and regulatory inspections. Cross-Functional Collaboration: Work closely with Engineering, Automation, Manufacturing, Quality Assurance, and Validation teams. Provide guidance and mentoring to junior CQV engineers and validation resources as needed.

Created: 2026-03-17