Engineer 2, Validation

Singapore, Tuas Singapore

Today, Lonza is a global leader in life sciences operating across three 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 a Validation Engineer. The role will provide day-to-day Validation activities support in accordance with approved SOPs / Policies for a GMP Biotech manufacturing facility.

Key responsibilities:

  • Supports Validation activities related to validation of facility, equipment utility, computer system, cleaning, and sterilization.
  • Support day-to-day Validation activities in accordance with approved Validation SOPs / Plan / Policies.
  • Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation / closure.
  • Collaborate with vendors and other Engineering functions to perform technical evaluation of the new equipment or modification, so as to develop appropriate protocol that will demonstrate that the equipment or modification meet the user or project requirements.
  • Participate in system design review to ensure compliance to 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 in the Biopharmaceutical industry.
  • Relevant 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 Systematic.
  • Team player, with strong focus on safety, quality and timelines.
  • Able to operate independently with minimum supervision.

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.

Reference: R53418