Process Validation / Senior Process Validation Engineer

at  Lonza

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.
As a Senior Process Validation Engineer, you will be responsible for leading the execution of PV activities/studies to support the timely and successful validation of new technology transfers into Lonza Singapore production facility and validate changes or continued validation for commercial customers.
The role will lead in the preparation for PV activities (ordering of materials, training) for assigned customer projects per pre-defined schedule and lead investigations into PV related discrepancies and deviations.

REQUIREMENTS

• Degree or higher from recognized institution in Engineering/ Science.
• 5 to 7 years’ experience in Validation unit or a related manufacturing environment in the Biopharmaceutical industry.
• Familiar with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
• Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility.
• Excellent oral and written communication skills, action orientation, and ability to work well in a cross-functional technical environment.
• Team player who can operate independently, with strong focus on safety, quality and timelines.
• Demonstrated track record in completing projects under tight timelines.
  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

• Lead in the execution of PV activities/studies that validate changes or continued validation for commercial customers, in accordance with approved SOPs / Policies / Regulatory requirements for Lonza Singapore
• Author validation protocols and reports
• Develop Validation Plans and ensure the validation execution activity meets scheduled timelines.
• Participate in review and approval of PV Protocols / Reports. Review minor/ major deviations.
• Provide floor and on-call support and coordination for PV activities being executed on the production floor. Maintain oversight of on-going PV activities on the production floor. Escalate issues to management appropriately and interface with customer on issue resolution. Follow all applicable MFG safety policies.
• Lead in the preparation for PV activities (ordering of materials, training) for assigned customer projects per pre-defined schedule.
• Lead investigations into discrepancies and deviations, author discrepancy reports or minor/major deviations.
• Identify and drive implementation of process improvements as required.
• Lead in the preparation of CPV reports and support preparation of APR.
• Perform work-stages review as required, to support customer BLA filing.
• Support change implementation on site and Manage change control implementation for changes that are driven by PV studies/improvement.
• Participate in inspections and audits by internal QA, customer and regulatory authorities as required.
• Review & assess Site Change Controls, implementation of Validation CAPAs and subsequent closure.
• Represent PV as a team representative in IPT/JPTs.
• Participate in on-job training program for staff and provide guidance to team members as required.
• Any other duties as assigned by your supervisor/manager.