Validation Engineer Lead – GMP Biotech (On-site Tuas)

Lonza Biologics Tuas Pte Ltd; Singapore; On-site; Confidential; Full time

Benefits offered by this job

Agile career and dynamic culture

Inclusive workplace

Fully paid medical insurance

Daily company bus to Tuas site

Job summary

The Lonza Biologics Tuas site in Singapore is seeking a Validation professional to support day-to-day GMP validation activities for facility, equipment, utilities and processes. You will lead or support qualification life cycles from URS through DQ, IQ, OQ and PQ, develop validation plans and collaborate with Engineering, End-User and Quality teams to ensure compliant, timely execution.

This fully site-based role requires close in-person collaboration to maintain validated state and meet high

Qualifications

• GMP experience and strong understanding of regulatory requirements.
• Experience with validation of facility, equipment, utilities and processes.
• Knowledge of URS, DQ, IQ, OQ and PQ lifecycle.

Responsibilities

• Lead or support validation activities for facility, equipment, utilities and sterilization across the qualification lifecycle.
• Develop and execute Validation Protocols and Reports for chambers, utilities and lab equipment.
• Investigate discrepancies and support deviations investigations and closure.
• Review validation documents and ensure compliance with site and regulatory expectations.
• Coordinate with Engineering, End-User and Quality teams to maintain validated state.
• Participate in audits and provide training to Validation staff.

Skills

GMP experience

Regulatory knowledge

Validation methodologies

Risk-based approach

Training & mentoring

Education

Degree in engineering related fields

Tools

Kneat GX

Trackwise

Job description

The Lonza Biologics Tuas site in Singapore is seeking a Validation professional to support day-to-day GMP validation activities for facility, equipment, utilities and processes. You will lead or support qualification life cycles from URS through DQ, IQ, OQ and PQ, develop validation plans and collaborate with Engineering, End-User and Quality teams to ensure compliant, timely execution.

This fully site-based role requires close in-person collaboration to maintain validated state and meet high