Cleaning Validation Specialist

About the role

We are seeking an experienced Cleaning Validation professional to lead validation activities for manufacturing equipment and facilities within a pharmaceutical environment. The role involves designing validation strategies, executing studies, and ensuring compliance with global regulatory standards.

Key responsibilities

• Plan, execute, review, and maintain cleaning validation activities for equipment and facilities.
• Prepare and review Validation Master Plans, protocols, reports, risk assessments, and SOPs.
• Design cleaning validation strategies, including worst‑case product selection, sampling methods, acceptance criteria, and recovery studies.
• Perform cleaning validation studies for new equipment, products, and change‑control activities.
• Coordinate and execute process validation activities, from protocol preparation to data analysis and reporting.
• Support equipment qualification (IQ, OQ, PQ) and investigate validation deviations and OOS results.
• Participate in regulatory audits and inspections, providing validation documentation and responses.
• Collaborate with Manufacturing, QA, QC, Engineering, and Regulatory teams to ensure timely completion of validation tasks.

Required profile

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, Chemical Engineering, or related life‑science discipline.
• 6–8 years of hands‑on experience in cleaning validation and process validation within pharmaceutical manufacturing.
• Strong knowledge of cGMP, data integrity (ALCOA+), and regulatory requirements (US FDA, EU GMP, PIC/S, WHO, ICH).
• Experience handling regulatory audits and inspections is preferred.

Required skills

• Cleaning validation concepts and MACO calculations
• PDE/HBEL‑based cleaning limits
• Swab and rinse sampling techniques
• Recovery studies and validation documentation
• Process validation and equipment qualification (IQ, OQ, PQ)
• Risk assessment tools
• cGMP compliance
• Data integrity (ALCOA+)
• Regulatory guidelines: US FDA, EU GMP, PIC/S, WHO, ICH