Engineer 2, Validation

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 3, Validation. 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 validation of facility, equipment utility, computer system, cleaning, and sterilization.
• Support day-to-day Validation activities in accordance with the approved Validation SOPs / Plan / Policies.
• Develop and complete Validation Protocols and Reports, including supporting site discrepancies and deviations investigation/closure.
• Work together with vendors and Engineering teams to evaluate new equipment or modifications. This will help develop protocols that prove the equipment meets project requirements.
• Participate in system design review to ensure compliance with user requirements, good engineering practice, validation requirements, and regulatory standards.
• Collaborate with other Engineering functions, End-User, and Quality team to ensure the Validation activities are completed as planned.
• Review Engineering documents associated with commissioning and validation activities.
• Participate in Site Validation Maintenance Program.
• Participate in commissioning activities when required.
• Support Change Implementation on site.
• Support Customer/Agency Audits and Inspections as required.
• Assist with implementation of department training requirements.
• Any other tasks as and when assigned by supervisor/manager.

Key requirements:

• Bachelor Degree / Diploma with exposure to the Biopharmaceutical industry.
• Meaningful work experience in Validation/Quality unit in the pharmaceutical/biotech industry.
• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP, and ICHQ7).
• Fair knowledge and experience of the practical and theoretical requirement of validation program in a GMP facility.
• Good oral and written communication skills.
• Meticulous and Methodical.
• Phenomenal teammate, with a strong emphasis on safety, quality, and timelines.
• Able to operate independently with minimum supervision.