Lead Validation Engineer, GMP Biotech (Singapore)

Lonza Group; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Dynamic career culture

Inclusive and ethical workplace

Performance-based compensation

Fully paid medical insurance (option:

Daily bus from MRT to Tuas site

Job summary

Lonza Group in Singapore Tuas is seeking a dedicated Validation role to provide day-to-day activities support for GMP Biotech manufacturing. This on-site position emphasizes real-time collaboration and precise validation execution to maintain high-quality and safe medicines.

You will lead or support validation of facilities, equipment, utilities and sterilization through URS to PQ, ensuring adherence to SOPs and continuous improvement across site operations.

Qualifications

• Engineering degree required.
• Familiarity with Kneat GX and TrackWise is a plus.
• GMP experience and knowledge of regulatory requirements is essential.

Responsibilities

• Lead or support validation activities from URS to PQ across facility, equipment, utilities and sterilization.
• Develop and execute validation protocols and reports (temperature chambers, clean utilities, EMPQ, autoclave, lab equipment).
• Investigate and resolve discrepancies and deviations from qualification activities.

Skills

GMP experience

Regulatory knowledge

Validation methodologies

Risk-based approach

Education

Degree in engineering related fields

Tools

Kneat GX

TrackWise

Job description

Lonza Group in Singapore Tuas is seeking a dedicated Validation role to provide day-to-day activities support for GMP Biotech manufacturing. This on-site position emphasizes real-time collaboration and precise validation execution to maintain high-quality and safe medicines.

You will lead or support validation of facilities, equipment, utilities and sterilization through URS to PQ, ensuring adherence to SOPs and continuous improvement across site operations.