About the role
We are looking for a dedicated and detail-oriented Fill and Finish Project Specialist to join our growing biopharmaceutical manufacturing team. In this role, you will be responsible for overseeing the execution of critical projects related to aseptic operations for the final formulation, filling, visual inspection, and labeling of gene therapy products under GMP conditions. Your contributions will directly impact the delivery of life-changing therapies for patients worldwide.
Key Tasks:
- Provide expertise on aseptic filling processes
- Track department projects while managing team workload.
- Execute business cases to support ongoing initiatives.
- Oversee capital projects to ensure the company’s objectives and compliance are met.
- Support the production planner in coordinating schedules and resources.
- Collaborate with the team to identify continuous improvement activities and implement them effectively.
- Manage CapEx and OpEx control processes.
- Conduct resource analysis for project requirements.
- Ensure the development and implementation of efficient processes
- Enhance process performance, reduce costs, and improve overall efficiency
- Oversee the preparation of detailed internal project documentation
- Collaborate with the Quality Assurance team to prepare for audits and inspections
- Manage a large group of internal resources to communicate internal project objectives.
- Foster a culture of high-performance and transparent cross-functional collaboration.
Key Working Relation:
- Reports functionally to Fill & Finish Manager
- Manufacturing departments
- Quality departments
- Engineering departments
