This Aseptic Technician I, is responsible for executing department specific tasks in accordance with all applicable cGMPs and compliant with Corporate/site procedures, regulations and policies.
Filling/Lyophilization/ Capping: Fill vaccines into respective presentations. Includes running multiple fill lines per our regulatory filings and local procedures in a clean room setting. Lyophilizing vaccine and final capping of product. Involves working with portable and stationary equipment and steam.
- Execution of aseptic techniques and clean room procedures or support area procedures in a GMP facility.
- Maintain appropriate departmental cGMP documentation.
- Execute all written procedures, to include Batch Records and SOPs.
- Follow and comply with all financial procedures
- Follow and comply with all site safety procedures.
- Operation of departmental equipment to include set up and take down.
- Effectively work in a team environment and communicate with multiple departments.
Education and Experience
- Clean room gowning required.
- Aseptic processing skills necessary while working in a small team while in a clean room setting.
- Set up, run (filling) and tear down of fill line equipment.
- Maintain accurate inventory.
- Load/ unload freeze dryers to complete the lyophilization process when applicable.
- Capping: Applying an aluminum seal when applicable.
•High school education or GED required.
•Post High School education in the Sciences or other related disciplines preferred.
• Good mathematical, science and computer skills preferred.
• Demonstrated teamwork and collaboration skills required.
- Strong communication skills required.
- Must be able to stand for long periods of time.
- Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.
- Must be able to work scheduled 40 hours with the ability to work overtime as needed.
- Must be comfortable in working in varying temperatures
- Frequent lifting and carrying of 5 to 25 lbs
- Regular reaching, bending, stooping, and twisting
- Repetitive motion and substantial movement of the wrists, hands, and/or fingers
- Willing to work any shift
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