Senior Engineer, Engineering - Validation

About the role

A fully site-based role at the Singapore Tuas site supporting day-to-day validation activities in line with approved SOPs and policies for a GMP biotech manufacturing facility. The engineer recommends improvements to the validation approach and site operations, collaborates with other site functions on improvement projects, and works closely with colleagues in person.

Key responsibilities

• Develop and maintain the Validation Master Plan (VMP) for onsite computerized system validation
• Use risk-based assessments (e.g. FMEA) to prioritize validation activities for product quality and data integrity
• Develop and execute IQ, OQ and PQ protocols, and investigate and resolve discrepancies and deviations
• Review and approve validation protocols and reports, including deviation investigations and closure
• Review the site validation maintenance program so systems stay validated throughout their lifecycle
• Develop validation plans for small to medium change projects and evaluate engineering documents for commissioning and validation
• Evaluate equipment, processes and operations and propose improvements to safety and efficiency
• Review site change controls and validation CAPAs, and participate in customer and agency audits and inspections

Required profile

• Degree in engineering-related fields
• GMP experience
• Strong understanding of regulatory requirements, validation methodologies and risk-based approaches for cleaning and sterilization
• Coordination and communication skills with cross-functional teams such as quality and other engineering teams

Required skills

• Proficiency in electronic systems such as Kneat GX and Trackwise is a plus

What we offer

• An agile career and dynamic working culture in an inclusive, ethical workplace
• Compensation programs recognizing high performance
• Fully paid medical insurance with family enrollment at partially subsidized premiums
• Daily company bus from the MRT station near home to and from the Tuas site