Lead Validation Engineer (Biotech)

TL;DR

Lead Validation Engineer (Biotech): Developing and executing validation protocols for cleaning and sterilization systems in a biotech manufacturing environment with an accent on CIP, COP, and SIP processes. Focus on ensuring regulatory compliance (FDA, EU GMP), performing risk assessments, and optimizing manufacturing safety standards.

Location: Fully site-based in Tuas, Singapore

Company

A global leader in biotech manufacturing with over 30 sites across five continents, focused on producing the medicines of tomorrow.

What you will do

• Develop, execute, and review validation protocols (IQ, OQ, PQ) and reports for cleaning and sterilization systems.
• Ensure compliance with regulatory guidelines (FDA, EU GMP), industry standards, and internal policies.
• Investigate and close validation discrepancies and deviations related to CIP, COP, and SIP systems.
• Collaborate with vendors and engineering teams to evaluate and validate new equipment and methods.
• Conduct risk assessments to establish parameters and acceptance criteria for validation studies.
• Support site validation maintenance programs and assist in regulatory inspections and customer audits.

Requirements

• Engineering or Life Science Diploma / Degree from a recognized institution.
• 5-8 years of experience in validation or operations.
• Specific expertise in CIP, COP, and SIP validation.
• Strong understanding of FDA and EU GMP regulatory requirements and risk-based approaches.
• Excellent analytical, problem-solving, and documentation skills.

Culture & Benefits

• Agile career path and dynamic working culture.
• Inclusive and ethical workplace environment.
• Performance-based compensation programs.
• Fully paid medical insurance with subsidized premiums for family members.
• Daily company bus transport from MRT locations to and from the Tuas site.