Senior Section Lead – Cleaning Validation
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.
The Senior Section Lead will be in charge of a team supporting validation for cleaning and/or sterilization. Role is responsible to ensure day-to-day Validation activities are performed in accordance with approved SOPs / Plans / Policies. Role is also responsible to provide leadership and oversight to all routine operational and administrative activities which occur within the individual’s team.
- Lead the team and plan resources to support day-to-day Validation activities in accordance with approved Validation SOPs / Plan / Policies for a multi-product, GMP biotech contract manufacturing facility.
- Support Manager in development of Validation Plans / strategies for supporting change implementation projects.
- Participate in planning for project implementation, including planning for validation resources, validation deliverables and overall project schedule.
- Reviewer and Approver of SOPs, protocols, reports or records.
- Review, approve, support deviation investigations, change controls, CAPA proposals and closure of discrepancy reports.
- Participate in system design review to ensure compliance to user requirements, good engineering practice, validation requirements and regulatory standards.
- Participate in planning of OPEX expenses and validation costs.
- Provide necessary guidance and assistance in problems solving and issues resolution, including appropriate escalation where needed.
- Provide on-the-job training through Performance Measure (PM) to support formalized technical and GMP training.
- Own and monitor team member’s training statuses and work with them to ensure their training is up to date.
- Leadership/managerial responsibilities for direct reports: examples include, provide leadership to subordinates by directing, mentoring, coaching and developing them towards personal
- growth, enhanced job performance and career satisfaction.
- Participate in Customer and Regulatory Audits, Gap analysis.
- Any other duties as assigned by your Supervisor/ Manager.
- Bachelor Degree / Diploma with exposure in the Biopharmaceutical industry.
- Relevant work experience in Validation / Quality /Manufacturing unit in the pharmaceutical/biotech industry.
- Familiarity 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 a GMP facility.
- Good oral and written communication skills.
- Meticulous and Systematic.
- Team player, with strong focus on safety, quality and 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.