Senior Technical Manager Aseptic Fill & Finish

As Senior Technical Manager Aseptic Fill and Finish, you will be responsible for overseeing and operating equipment for Aseptic filling, establishing and maintaining quality processes, and performing regulatory inspections. You will also collaborate with Quality and Engineering teams and provide technical leadership for new process implementation initiatives.

Requirements

• Oversee and operate equipment for Aseptic filling, sterilization operations in the cleanroom areas, ensuring adherence to GMP, safety, and quality standards
• Establish and maintain quality processes for vial filling, visual inspection, labelling, and packaging operations.
• Perform and oversee the operation, cleaning, and setup of aseptic filling machine and related equipment to maintain sterility.
• Act as a Subject Matter Expert (SME) for aseptic filling operations, providing technical guidance and support during regulatory inspections
• Lead site qualification of filling equipment and continuous process validations and ensure GMP requirements are met.
• Ensure adherence and compliance with batch records and SOPs
• Works closely with the production staff to troubleshoot process and equipment problems while ensuring appropriate and proactive internal stakeholder engagement.
• Ensure timely and efficient preventive and corrective maintenance activities are carried out as per maintenance schedule.
• Ensures the proper processes are in place for GMP and Safety training of staff, with a focus on Aseptic filling operations
• Provide technical training to operators, demonstrating proper aseptic techniques and conduct assessment and qualification of operators in line with BioNTech procedures.

Benefits

• Competitive remuneration package
• Support of diverse employee base