Lead Engineer, Engineering - Validation (Biotech)

Location: Fully site-based in Tuas, Singapore

Company

hirify.global operates globally connected biotech manufacturing sites that develop and manufacture medicines and therapies.

What you will do

• Lead and support validation of facilities, equipment, utilities, computer systems, and sterilization across URS, DQ, IQ, OQ, and PQ qualification stages.
• Develop and execute validation protocols and reports for temperature chambers, clean utilities, cleanrooms, autoclaves, manufacturing process equipment, and laboratory equipment.
• Investigate discrepancies, incidents, deviations, and CAPAs arising from qualification and validation activities.
• Maintain the Site Validation Maintenance Program and ensure systems remain in a validated state throughout their lifecycle.
• Develop validation plans for small- and medium-scale changes, coordinate execution with Engineering, end users, and Quality, and ensure delivery timelines are met.
• Support audits and inspections, review commissioning documents and change controls, and provide training to Validation staff.

Requirements

• Degree in an engineering-related field.
• Experience in GMP environments.
• Strong understanding of regulatory requirements, validation methodologies, and risk-based approaches for cleaning and sterilization processes.
• Ability to review and approve validation protocols, reports, discrepancies, and deviation investigations.
• Ability to work fully site-based at the Tuas manufacturing facility in Singapore.

Nice to have

• Proficiency with electronic systems such as Kneat GX and TrackWise.

Culture & Benefits

• Agile career environment and dynamic working culture.
• Inclusive and ethical workplace.
• Compensation programs recognizing high performance.
• Fully paid medical insurance, with family coverage available at partially subsidized premiums.
• Daily company bus service from an MRT location near home to the Tuas site.