Lead Engineer, Engineering - Validation

About the role

Lonza is hiring a Lead Engineer, Engineering - Validation for its GMP biotech manufacturing facility in Singapore Tuas. This is a fully site-based role supporting day-to-day validation activities in line with approved SOPs and policies, recommending improvements to the validation approach and site operations, and collaborating with other site functions to implement improvement projects.

Key responsibilities

• Lead or support validation of facility, equipment, utilities, computer systems and sterilization through the qualification lifecycle (URS, DQ, IQ, OQ, PQ)
• Develop and execute validation protocols and reports for temperature chambers, clean utilities, EMPQ clean rooms, autoclaves, bioreactors, BSCs, isolators and laboratory equipment such as HPLC
• Investigate and resolve discrepancies and incidents from qualification activities, and support validation-related deviations
• Review and approve validation protocols and reports, including discrepancies and deviation investigations
• Review the site validation maintenance program and develop validation plans for small to medium change projects
• Coordinate with Engineering, End-User and Quality teams, review commissioning and validation documents, and evaluate site change controls and validation CAPAs
• Propose improvements to equipment, systems, processes and operations, and participate in customer and agency audits and inspections
• Take part in on-job training and train validation staff

Required profile

• Degree in an engineering-related field
• GMP experience
• Strong understanding of regulatory requirements, validation methodologies and risk-based approaches for cleaning and sterilization

Required skills

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

What we offer

• A fully paid medical insurance plan, with family members at partially subsidized premiums
• Daily company bus from the MRT station near home to and from the Tuas site
• An agile career path, inclusive and ethical workplace, and compensation programs recognizing high performance