Senior Engineer, Engineering - Validation

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

Singapore, Tuas Singapore

The role will provide day-to-day Validation activities support in accordance with approved SOPs / Policies for a GMP Biotech manufacturing facility. Recommends improvements to the validation approach and site operations. Collaborates with other site functions to implement improvements projects.

This is a fully site‑based role at Singapore Tuas. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What You’ll Get

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.
• Daily company bus from the MRT location near your home to and from the Tuas site.

What You’ll Do

• Lead or support Validation activities related to validation of facility, equipment, utility, computer system and sterilization for the qualification life cycle from URS, through DQ, IQ, OQ and PQ.
• Develop & execute Validation Protocols and Reports related to:
  • Temperature Chambers (e.g. Freezers, cold room etc.)
  • Clean utilities (e.g. WFI, clean steam, process gas etc.)
  • EMPQ Clean room qualification, Autoclave, Manufacturing process equipment (e.g. bioreactors, BSC, Isolator)
  • Laboratory equipment (e.g. HPLC)
• Investigate and resolve discrepancies/incidents arising from qualification activities and support validation related deviations.
• Review and approve of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
• Perform Periodic review Site Validation Maintenance Program, ensuring systems remain in a validated state throughout their lifecycle.
• Develop Validation Plans for a small to medium scale change implementation project and ensure the validation execution activity meets scheduled timelines
• Coordinate with other Engineering functions, End-User and Quality team to ensure the Validation activities.
• Review Engineering documents associated with commissioning and validation activities
• Evaluate and propose improvement to equipment/system, processes and operations to improve safety and process efficiency.
• Review & assess Site Change Controls and Validation CAPAs.
• Participate in Customer / Agency Audits and Inspections.
• Participate in on-job training program and provide training to Validation staff.

What We’re Looking For

• Degree in engineering related fields
• Proficiency in electronic systems such as Kneat GX and Trackwise will be a plus.
• GMP experience
• Strong understanding of regulatory requirements, validation methodologies, and risk-based approaches for cleaning and sterilization processes.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R79736