Senior Engineer, Engineering - Validation

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:

• Develop and maintain the Validation Master Plan (VMP), outlining the overall approach to onsite computerized system validation.
• Use risk-based assessments (e.g., FMEA) to prioritize validation activities for product quality and data integrity.
• Developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• 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
• 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.

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.
• Coordination and communication skills with cross functional team (quality team, other engineering teams)

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.

Ready to shape the future of life sciences? Apply now.