Aseptic Technician III

Virus: Produce viral antigens in roller bottles and bioreactors in a clean room setting. Includes the preparation of continuous cell lines used for virus propagation and inactivation and concentration of viral fluids. Involves working with portable and stationary equipment and steam.

Working Hours

• 1st Shift: Monday - Friday, 6:00 AM – 2:30 PM
• Must be willing to work occasional weekends.

Position Responsibilities

• Execute, lead and trouble shoot aseptic techniques and clean room procedures or support area procedures with a high level of understanding in a GMP facility.
• Review, maintain and edit, as needed, appropriate departmental cGMP documentation.
• Execute and lead operation to comply with all written procedures, to include Batch Records and SOPs.
• Follow and comply with all manufacturing, inventory, and quality electronic systems as appropriate.
• Follow and comply with all financial procedures.
• Follow and comply with all site safety procedures. Identify ways to improve the safety culture of the department.
• Operation of departmental equipment to include set up and take down. Provide oversight as necessary.
• Assist in the preparation of daily production and work schedules.
• Effectively work in a team environment and communicate with multiple departments.

Virus

• Perform environmental monitoring and staging of clean rooms.
• Perform accurate cell counts.
• Manipulate roller bottles.
• Operate, clean, and sanitize concentration units.
• Operate and maintain bioreactors.
• Monitor and respond to BMS (Building Management System) alarms.
• Document production activities on paper and in computer-based systems.
• Order Media and Equipment.
• Manage the antigen production schedule and assign resources to the scheduled production activities.
• Lead, mentor, and train colleagues as needed.
• Provide department oversight as requested.

Education and Experience

• High school education or GED required.
• Post High School education in the Sciences or other related disciplines preferred.
• Previous experience in a manufacturing environment and / or Operator II level beneficial.
• Good mathematical, science and computer skills preferred.
• Demonstrated teamwork and collaboration skills required.
• Strong communication skills required.
• Demonstrated leadership and decision-making skills beneficial.
• Must be willing to work any shift.

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 comfortable in working in varying temperatures.
• Must be able to don proper PPE to include Tyvek gown.
• 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.