Lead Engineer, Engineering - Validation

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

Benefits offered by this job

Fully paid medical insurance

Daily company bus

Inclusive workplace

Agile career culture

Compensation programs recognizing high

Job summary

Lonza Singapore is hiring a Lead Engineer, Cleaning Validation for a fully site-based role at the Tuas facility. You will drive CIP, COP, and SIP validation activities to ensure compliance with FDA/EU GMP standards and internal policies.

You will develop, execute, and review IQ/OQ/PQ protocols and collaborate with engineering, quality, and operations to deliver timely validations and continuous site improvement.

Qualifications

• Engineering or Life Science degree from a recognized institution.
• 5-8 years in validation or operations, with CIP/COP/SIP experience.
• Strong knowledge of FDA/EU GMP regulations and risk-based validation.
• Excellent analytical, problem-solving, and documentation skills.

Responsibilities

• Support CIP/COP/SIP validation activities and generate protocols.
• Develop and review IQ/OQ/PQ validation reports.
• Collaborate with suppliers, engineering, QA, and operations to execute validations.
• Assist in regulatory inspections and audits.
• Contribute to validation maintenance and revalidations.
• Support change control and training initiatives.

Skills

Analytical thinking

Problem-solving

Documentation

Team collaboration

Education

Engineering or Life Science Diploma / Degree

Job description

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.

Lonza is currently looking to hire a lead Engineer, Cleaning Validation with experience in Cleaning-in-Place (CIP), Cleaning-out-of-Place (COP), and Sterilization-in-Place (SIP) to support validation activities across our facility. This remarkable opportunity allows you to join a world‑class team, where your work will directly contribute to flawless biotech manufacturing processes. Our ambitious vision is to successfully implement innovative solutions that make a positive difference. If you have the determination to inspire change, this is the role for you.

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 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:

• Support validation activities related to CIP, COP, and SIP validation, ensuring compliance with regulatory guidelines, industry standards, and internal policies.
• Develop, execute, and review validation protocols (IQ, OQ, PQ) and reports for cleaning and sterilization systems.
• Assist in the validation of facility, equipment, utilities, and computer systems, with a primary focus on cleaning and sterilization processes.
• Support day-to-day validation activities in alignment with approved SOPs, validation plans, and policies.
• Investigate and close validation discrepancies and deviations related to CIP, COP, and SIP systems.
• Work closely with vendors and engineering teams to evaluate new CIP, COP, and SIP equipment and methods or modifications, ensuring proper validation strategies.
• Participate in system design reviews to verify compliance with user requirements, engineering best practices, and validation standards.
• Conduct risk assessments to establish parameters and acceptance criteria for cleaning and sterilization validation studies.
• Collaborate with engineering, quality, and operations teams to ensure timely completion of validation activities.
• Review and approve engineering documents associated with cleaning and sterilization validation activities.
• Support site validation maintenance programs, including periodic revalidation of CIP, COP, and SIP systems.
• Assist in regulatory inspections, customer audits, and compliance assessments.
• Support commissioning activities as required.
• Assist in change implementation related to CIP, COP, and SIP systems.
• Contribute to training initiatives within the validation department.
• Perform additional tasks as assigned by the supervisor or manager.

What we’re looking for:

• Engineering or Life Science Diploma / Degree from recognized institution
• 5-8 years in validation or operations, with experience in CIP, COP, and SIP validation
• Strong understanding of regulatory requirements (FDA, EU GMP), validation methodologies, and risk-based approaches for cleaning and sterilization processes.
• Excellent analytical, problem-solving, and documentation skills. Ability to work collaboratively across 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.

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