Description:
Under the direction of the Manufacturing or Packaging Supervisor, or another qualified Operations Specialist, you will perform a wide variety of tasks and operations required to formulate, fill, inspect, and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility. You will troubleshoot, maintain, and assemble all production equipment as required, and assist the Operations Specialist with major equipment overhauls, repairs, and installations as necessary. All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and Genentech standards.
You must be available to work any shift including nights, weekends and holidays.
The Opportunity:
- Perform safety and housekeeping audits and duties as required.
- Assist in set up, change over, and test run equipment for various-sized vials and packages as required.
- Supporting the Operations Specialist Maintenance, and/or outside services in the repair, maintenance, and calibration of GNE Systems as required.
- Assist in the development of plant SOP’s and training materials. Perform training of other Technicians.
- Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
- Operate all formulation, sterile filling, inspection, and final vial packaging equipment in the plant.
- Perform preparation of sterile components.
- Perform bulk thaw, dilution, and formulation operations.
- Performing manual inspection of empty vials and filled product with a focus on quality and efficiency.
- Conduct environmental monitoring activities in the manufacturing areas as required.
- Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
- At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
- Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
Who you are:
- 1-2 years (within the last 7 years) experience in the operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers is highly desirable.
- Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other medical industries.
- Must be computer literate, including ability to interface with computer systems and PLC-based logic.
- Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and email. Should possess basic typing skills.