Reporting to the Team Leader, the role of the Process Technician (Aseptic Filling) is to provide the production skills sets necessary to complete sterile filling processing operations to achieve the production schedule in a safe, cGMP compliant, and cost-effective manner.

Responsibilities

• Perform sterile filling process operations using cGMP, Batch records, SOPs, whilst in full compliance with local SOPs, HSE risk management procedures. Thereby achieving the production schedule and requirements.
• Move materials required in Filling (pallet trucks, pallet tanks, rigs ) using cGMP, BR systems, and in full compliance with local SOPs and HSE risk management procedures. In order that the production schedule and requirements are met.
• Perform basic area cleaning to maintain Environmental Monitoring, GMP and Health and Safety standards.
• Perform in Process Control checks and Environmental Monitoring so that process operations are maintained in control and products made in specification.
• Complete documentation to the required standards of accuracy, and cGMP compliance, including raising work orders and HSE incident reports. Can provide first response on PCS, GLIMS, SAP issues and exceptions.

• Fill of sterile products / Aseptically qualified (e.g., sterile connections, sterility assurance) / Use Isolator technology and high personal standards of compliance with relevant site and area procedures.
• Proven knowledge of cGMP. Computer competent (e.g., PCS, GLIMS, SAP).
• Documentation skills (based on literacy and numeracy) and able to operate material moving equipment such as pallet trucks (manual & electronic)
• Working experience in a cGMP and sterile product production operations in Biotech or Pharma industry

• Degree Qualification preferred