Lead Engineer, Validation (CSV)

As a Senior/Lead Computer System Validation (CSV) Engineer you are responsible for ensuring that computerized systems used in regulated environments (GxP) function as intended, maintain data integrity, and comply with international regulatory standards. To bridge the gap between IT, automation engineering, and quality assurance to ensure product safety and quality

What you will get

- An agile career and dynamic working culture.

- An inclusive and ethical workplace.

- Compensation programs that recognize high performance.

- Fully paid medical insurance, with subsidized premiums for family members.

- Daily company bus from an MRT location near your home to the Tuas site.

- Access to learning and professional development resources.

- A chance to contribute to safe and efficient site operations.

What you will 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.

- Validation Summary Reports to provide an overview of validation results and final status.

- Change control and deviation management processes to oversee alterations to validated systems and address deviationsduring validation.

- Serving as a subject matter expert during regulatory audits.

- Scheduling and coordinating validation efforts with external partners.

- Collaborated across functions for on-time project completion and supervised junior validation engineers with technical support.

What we are looking for

- At least five years of experience in computer systems validation within a regulated or manufacturing environment.

- Knowledge of cGMP, GDP, and GEP principles.

- Strong problem‑solving and analytical skills.

- Ability to manage multiple priorities and collaborate across teams.

- Proficiency with spreadsheets, databases, and word‑processing tools.

- Ability to review engineering documents related to commissioning and validation.

- Drive to improve systems, processes, and operations to enhance safety and efficiency.

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 onboard.

Ready to shape the future of life sciences Apply now.