Senior Engineer, Engineering - Validation (Biotech)

Location: Fully site-based in Tuas, Singapore

Company

hirify.global operates more than 30 sites across five continents and manufactures medicines and life-science products for customers worldwide.

What you will do

• Lead or support validation of facilities, equipment, utilities, computer systems, and sterilization throughout the qualification lifecycle from URS through DQ, IQ, OQ, and PQ.
• Develop and execute validation protocols and reports for temperature chambers, clean utilities, cleanrooms, autoclaves, manufacturing process equipment, and laboratory equipment.
• Investigate qualification discrepancies, incidents, deviations, and CAPAs, and support their resolution and closure.
• Maintain validation programs and ensure systems remain in a validated state throughout their lifecycle.
• Develop validation plans for change implementation projects and coordinate execution with Engineering, end users, and Quality teams.
• Review commissioning and validation documentation, participate in audits and inspections, 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 work fully site-based in Tuas, 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 focused on collaboration, accountability, excellence, passion, and integrity.
• Performance-recognition compensation programs.
• 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.