Aseptic Technician I

States considered:
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.
Working Hours:
Monday - Friday, 6:00 AM – 2:30 PM
Weekend, every third weekend as needed
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.
Filling:
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 freeze dryers to start the lyophilization process when applicable.
Capping: Applying an aluminum seal when applicable.
Education and Experience:
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.
Physical Requirements:
Must be able to sit, stand, and walk for long periods of time.
Must be able to wear a respirator.
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 able to don proper PPE to include Tyvek gown.
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 off-shift.
Full time
Regular
Colleague
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