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Engineer 2, Validation
2 weeks ago
Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience - we, in Singapore are proud to be part of this global network.
Lonza is currently looking to hire an Engineer 2, 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.
**Key responsibilities**:
- 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.
**Key requirements**:
- Engineering or Life Science Diploma / Degree from recognized institution
- 3-4 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.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
