Fill & Finish Operator
About the role:
We are looking for a dedicated and detail-oriented Fill & Finish Operator to join our growing biopharmaceutical manufacturing team. In this role, you will be responsible for the execution of aseptic operations for the final formulation, filling, visual inspection, and labeling of gene therapy products under GMP conditions. You will contribute directly to the delivery of life-changing therapies for patients worldwide.
Key Tasks:
- Collaborate in achieving the production objectives set by the company in a timely manner.
- Collaborate in the creation of the documentation associated with their sector according to the established plans and the quality required by the company, as well as the execution of the production activities by the personnel of the sector in accordance with GMP regulations.
- Respect safety standards in the workplace.
- Manage the agreed planning for the final filling stages as part of the production process.
- Detect and warn of situations that may endanger either the person or the product and propose solutions accordingly.
- Perform the environmental monitoring process.
- Fill out and review documentation according to GMP regulations.
- Manage material orders to be able to execute the processes with guarantees in terms defined in the manufacturing process.
- Respect GMP regulations during the execution of assigned tasks.
- Be a technical reference and leader within the sector for the final filling operators.
- Interact with the rest of the company's departments in order to meet the objectives set.
Key Working Relations
Internal:
- Reports functionally to Fill & Finish Lead
- Manufacturing departments
- Quality departments
- Engineering departments
External:
- Equipment Vendors
- Contract Testing Labs
Skills & Qualifications:
- Bachelor’s degree in Biotechnology, Pharmacy, Engineering, or a related field.
- Minimum of 2 years of experience in the manufacturing area.
- Knowledge of cleanroom procedures, gowning, and aseptic techniques.
- Familiarity with GMP documentation and regulatory requirements.
- High attention to detail, reliability, and ability to work in highly regulated environment.
- Excellent problem-solving and analytical skills, with a data-driven approach to decision-making.
- Strong communication and interpersonal skills, with the ability to collaborate effectively across functions.
- Company values: Humility, Empathy, Responsibility, Commitment, Teamwork, and Effort.
