Validation Engineer

Company : Katalyst Healthcares & Life Sciences

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.
• Author, 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:

• Act 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.

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