Associate Manager, Engineering - 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 ? 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 Associate Manager, Engineering – Validation, will lead the Engineering Validation team. Role is responsible for ensuring the site Validation lifecycle program is compliant to regulatory requirements. The role also involves providing leadership and mentorship to all routine operational and administrative activities.
Key responsibilities:
- Lead day-to-day Validation activities in accordance with approved Validation SOPs / Plan / Policies.
- Participate in the review and approve of Validation SOPs / Plans to facilitate the implementation of the Validation Strategy defined by the Validation Master Plan.
- Lead internal and external validation resources deployment to achieve department / project goals.
- Liaise with system owner, quality unit and relevant departments including clients to ensure scope, execution and reporting of Validation Program meets their expectations.
- Plan & handle on-job training program for staff. Perform regular review of department training requirements; identify gaps & improvements.
- Participate as needed in regulatory inspections and audits, and respond to validation-related matters.
- Plan, schedule, and own the validation efforts for large scale change implementation project in accordance with current Good Manufacturing Practices (cGMPs).
- Recruitment and resources planning (Staff acquisition -interns/internal/external).
- Lead direct reports by advising, mentoring, coaching for personal growth, improved job performance, and career happiness.
- Provide oversight for validation deviation investigation to resolve execution or result discrepancies and participate in the resolution of deviations and corrective/preventive actions.
- Uphold data integrity principle in accordance to Lonza policies. Proactively evaluate, identify and improve data integrity process.
Key requirements:
- Bachelor Degree / Diploma with exposure in the Biopharmaceutical 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 GMP facility.
- Good leadership and strong communication skills.
- Exhibit good quality decision making traits.
- Meticulous, Detailed and with Analytical Approach
- People management experience in similar capacity (Validation Senior Section Manager, etc).
- Ability to define specific goals clearly, to develop and prioritize activities (Validation Senior Section Manager).
- Great teammate, with a strong focus on safety, quality, and timeline.
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.