Associate Department Manager, Process Validation, MSAT
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.
Lonza’s Singapore, Tuas location is searching for an experienced Process Validation Associate Department Manager to join our amazing Manufacturing Science and Technology (MSAT) team. Working within MSAT, you will be responsible for the day to day of process validation activities and ensure proper implementation of process validation and re-validation requirements in accordance with Site GMP Policy.
- Manage day-to-day process validation activities in accordance with approved Validation SOPs / Plan / Policies for a large scale, multi-product, GMP biotech contract manufacturing facility.
- Participate in review and approval of Validation SOPs / Plans / Protocols / Reports including site discrepancies and deviations investigation / closure.
- Drive the implementation of process validation Program and re-Validation requirements are performed in accordance with approved Site Policies / Plans / SOPs.
- Identify issues and gaps, improvement strategies & generation of validation review reports.
- Provide review and assessment of associated change requests related to processes.
- Provide oversight for validation deviation investigation to resolve execution or result discrepancies and participate in the resolution of deviations and corrective/ preventive actions.
- Supervise on-job training program for staff and conduct site-wide training when required.
- Perform & document detailed evaluation on critical validation processes and/ or studies, including justification/ rationale for approach, methodology, acceptance criteria and impact to product quality.
- Plan/ supervise/ manage internal and external validation resource deployment to achieve department/ project goals.
- Effectively communicate issues to Lonza management (PM, MSAT, Manufacturing, QA), independently develop plan for resolution and drive resolution with customer technical and QA groups with a strong sense of urgency to minimize process impact.
- Participate in co-ordination meeting with system owners, quality unit and relevant departments including clients to ensure scope, execution and reporting of Validation activities meets expectations, and assist in resolution of issues/ problems and de-bottlenecking of road blocks.
- Serve as SME during customer and regulatory audits.
- Assist in development/ implementation of departmental Plans/ Policies.
- Lead multifunctional teams within Lonza and globally to address site/network improvement projects.
- Sets individual personal development goals and provides appropriate coaching and performance feedback.
- Utilize team members in an efficient and effective manner through cross training/ flexible resource planning.
- Any other tasks as and when assigned by department head.
- Diploma/ Degree or higher from recognized institution in Engineering/ Science.
- Significant years of experience in process validation or a related manufacturing environment in the biopharmaceutical industry
- Previous people management experience including recruitment, training, development and mentoring/ coaching of technical staff.
- 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 process validation program in GMP facility.
- Good time management, planning, prioritization and delegation skills.
- Ability to manage change and communicate it effectively.
- Influencing skills, assertiveness and an ability to challenge views and beliefs.
- Strong independent work ethic.
- Excellent communication skills, outstanding action orientation, and ability to work well in a cross-functional technical environment.
- Excellent technical writing skills, ability to provide attention to detail is essential.
- Ability to manage multiple priorities in a fast paced, pressured environment.
- 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 achieve 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.