Aseptic Technician I – Filling/Lyo/Capping

Charles City

Full time

JR00012675

 

Position Summary:

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.

 

Position Responsibilities:

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/ unload freeze dryers to complete 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 stand 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.
  • 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