Senior Validation Engineer – GMP Biotech (Onsite)

Lonza; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Fully paid medical insurance

Company bus from MRT to Tuas site

Inclusive workplace

Job summary

Lonza in Singapore Tuas is seeking a hands-on Validation Specialist to lead and support validation activities across facility, equipment, utilities, and process equipment, ensuring compliance with URS, DQ, IQ, OQ and PQ.

You will develop validation protocols and reports for temperature-controlled systems and clean utilities, with collaboration across Engineering, End-User, and Quality teams to maintain validated state throughout lifecycle.

Qualifications

• Degree in engineering related fields.
• GMP experience and familiarity with validation principles.
• Knowledge of regulatory requirements and risk-based approaches for cleaning and sterilization.

Responsibilities

• Lead or support validation activities for facility, equipment, utilities, CS, and sterilization throughout URS, DQ, IQ, OQ, PQ.
• Develop and execute Validation Protocols and Reports for Temperature Chambers, freezers, and cold rooms.
• Handle clean utilities (WFI, clean steam, process gas).
• Qualify Autoclave, bioreactors, BSC, Isolator, and HPLC equipment.
• Investigate discrepancies and deviations in qualification activities and support deviation closure.

Skills

GMP experience

Kneat GX

TrackWise

Regulatory knowledge

Education

Degree in engineering related fields

Tools

Kneat GX

TrackWise

Job description

Lonza in Singapore Tuas is seeking a hands-on Validation Specialist to lead and support validation activities across facility, equipment, utilities, and process equipment, ensuring compliance with URS, DQ, IQ, OQ and PQ.

You will develop validation protocols and reports for temperature-controlled systems and clean utilities, with collaboration across Engineering, End-User, and Quality teams to maintain validated state throughout lifecycle.