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.
• 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.