Please note this is a Contract position up to 3 years, could lead to a full time Genentech opportunity. There are multiple shifts available (day or night, compressed).
Main Purpose of the Position:
Under the direction of Manufacturing Supervisor or other qualified Operations Specialist, perform a wide variety of tasks and operations that are required to formulate, fill, inspect and package sterile pharmaceutical products in a state-of-the-art, automated production and packaging facility. Troubleshoot, maintain, and assemble all production equipment as required. Assist the Operations Specialist on 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.
In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits:
- Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
- Embraces Class A principles and behaviors.
- Continuously in search of ways to maintain the highest levels of productivity.
Actively participates in a teamwork environment that maintains a high performance culture.
Please note this is a Day Shift position,6:00am to 6:30pm Thursday through Saturday (every other Wednesday)
- Adhere to all plant safety policies and procedures and proactively identify unsafe conditions Perform safety and housekeeping audits 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 Genentech systems as required
- Perform training of other Technicians
- Assist in the development of plant SOP's and training materials
- 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 material handling in the plant as required
- Perform preparation of sterile components
- Assist in the cleaning, set-up, sterilization, and dis-assembly on a variety of processing equipment 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 Perform cleaning and housekeeping duties as required
Qualifications / Requirements:
- Proficiency in the English language - reading, writing, and communication
- Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended periods of time
- In addition, all candidates must pass a vision acuity and color discrimination test
- Must complete periodic physical examinations to identify medical conditions which pose a risk to Grade C or higher operation
- Must have 1 to 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, 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 e-mail. Must possess basic typing skills