Senior Validation Engineer - GMP Biotech (Singapore)

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

Benefits offered by this job

Agile career culture

Inclusive workplace

Compensation programs that recognize高绩

Job summary

Lonza Singapore Tuas site is seeking a Validation Specialist to provide day-to-day validation support in line with SOPs and GMP requirements. The role collaborates with site functions to implement improvements on the validation approach and site operations.

The position is fully site-based, enabling real-time collaboration and precision in manufacturing medicines to high quality and safety standards. Applicants should have engineering background and GMP experience.

Qualifications

• GMP experience is required.
• Strong understanding of regulatory requirements and validation methodologies.
• Risk-based approaches for cleaning and sterilization processes.

Responsibilities

• Lead or support Validation activities related to facility, equipment, utility, computer system and sterilization.
• Develop & execute Validation Protocols and Reports for temperature chambers, clean utilities and lab equipment.
• Investigate discrepancies and deviations arising from qualification activities.
• Review and approve Validation Protocols/Reports including site discrepancies.
• Conduct periodic reviews of Site Validation Maintenance Program.
• Develop Validation Plans for small to medium change projects and ensure timely execution.
• Coordinate with Engineering, End-User and Quality teams on validation activities.
• Review engineering documents associated with commissioning and validation.
• Evaluate improvements to equipment and processes for safety and efficiency.
• Participate in Site Change Controls and Validation CAPAs.
• Assist in customer/agency audits and inspections and provide validation training.

Skills

GMP experience

Kneat GX

Trackwise

Regulatory knowledge

Education

Degree in engineering related fields

Tools

Kneat GX

Trackwise

Job description

Lonza Singapore Tuas site is seeking a Validation Specialist to provide day-to-day validation support in line with SOPs and GMP requirements. The role collaborates with site functions to implement improvements on the validation approach and site operations.

The position is fully site-based, enabling real-time collaboration and precision in manufacturing medicines to high quality and safety standards. Applicants should have engineering background and GMP experience.