Purpose:
Manufacture of bulk biologics products. Perform cleaning and sterilization procedures. Perform process tests and participate in qualification and validation activities as required. Assemble and inspect equipment in the manufacturing area to confirm operational status. Work is performed in aseptic and non-aseptic environments.
Responsibilities:
- Operate manufacturing equipment and instruments, such as tanks, autoclaves, filtration systems, washers, filter integrity testing, pH, amongst others. Conduct equipment setup (CIP, PT, SIP) operations according to the established procedures.
- Manufacture of bulk biologics operations in Media & Buffer Formulation (Central Services), Inoculum or Fermentation (Upstream) and Capture or Purification (Downstream) areas according to approved and effective procedures.
- Conduct equipment and facility inspections and advise of situations that affect operating and environmental conditions. Monitor critical parameters and elevate any deviation that could impact operations to address accordingly.
- Provide technical assistance to manufacturing areas, specifically the troubleshooting support of equipment and process events.
- Receive, inspect and verify materials availability to be used for the production activities.
- Document, audit and timely correct manufacturing electronic or paper batch record discrepancies.
- Document process and equipment status in electronic or manual records.
- Sample collection and processing as required by the process.
- Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete process-associated documentation.
- Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties..