1+ months

Manufacturing Technician - Bioprocess

Genentech
South San Francisco, CA 94080

The Manufacturing Technician is responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems in a cGMP manufacturing environment. The individual will operate production equipment for our Cell Culture, Purification, Bulk Processing, Filling, Inspection and/or Support Services groups. This may include culture growth monitoring, process monitoring, in-process sampling, harvesting operations, protein purification, bulk formulation, fill line operations, lyophilization, bulk freeze/thaw, transfer operations, inspection, and equipment set up/ changeover. May also perform preparation of media, raw materials pre-weigh kits, and buffer solutions. The individual will be required to work in and maintain a clean room environment with aseptic processing in accordance with Standard Operating Procedures (SOPs). Must maintain batch records and associated documentation to comply with regulatory requirements and current Good Manufacturing Practices (cGMP). Area of work must remain in a high state of inspection readiness at all times.

This position is for a night shift and may fall under one of these two shifts:

  • Sun- Tues, alternating Sat from 1900-0800
  • Wed- Fri, alternating Sat from 1900-0800

Responsibilities

  • Operate systems that clean and sterilize tanks and filtration systems.
  • Prepare solutions for the production process.
  • Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
  • Troubleshoot equipment and process problems.
  • Comply with safety requirements, cGMP, SOP and manufacturing documentation.
  • Use automation to perform production operations.
  • Operate automated systems for equipment operation.
  • Assemble and prepare equipment for production
  • Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.
  • Operate systems that clean and sterilize tanks and filtration systems.
  • Prepare solutions for the production process.
  • Review documentation and check all calculations (e.g. tickets, labels, equipment reading).
  • Troubleshoot equipment and process problems.
  • Comply with safety requirements, cGMP, SOP and manufacturing documentation.
  • Use automation to perform production operations.
  • Provide support to Manufacturing to meet production demands
  • Operate automated systems for equipment operation.
  • Assemble and prepare equipment for production
  • Work with coworkers and supervisor to effectively troubleshoot equipment and process issues.
  • Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture in which no one gets hurt.

Qualifications

  • Bachelor's degree preferably in Life Sciences or engineering with 3+ years of relevant experience, or Associate's degree and 5+ years of experience, or High School diploma and 7+ years experience.
  • Biotech certificate from approved programdesirable.
  • Ability to understand high levels of automation and technical process knowledge within area of responsibility.

  • Background in fermentation, purification, or fill/finish operation strongly preferred.

  • Background on equipment set up and change over desirable

  • Excellent oral and written communication skills.

  • Problem solving skills.

  • Lean production system experience desired.

  • Capable of writing detailed reports and summaries.

  • Familiarity of computer-based systems.

  • Detail oriented documentation skills.

  • Communicate effectively and ability to work in a team environment.

  • Professional interpersonal skills.

Physical Demands/Work Environment/Safety Considerations

  • Schedule could include a non-rotating 3 or 4-day (12 hour shift including one weekend day), evening or night hours.

  • Expected to be on feet for 8 to 12 hours a day.

  • Climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility.

  • Able to lift and carry up to 40 lbs. Push and/or pull with force of 50lbs with full body, and Push/Pull force of 24lbs with arms only may be required.

Working within a clean room environment requires:

  • Gowning in the form of hospital scrubs, coveralls, gloves, and steel toe boots.

  • No makeup or jewelry can be worn when working in the cleanroom environment.

  • Comfortable working in areas with large mechanical equipment, process piping, pumps, pressurized vessels, which can occasionally create a loud working environment.

  • Must wear personal protective equipment in accordance with workplace hazards.

  • Work with hazardous materials and chemicals.

*This position is not eligible for relocation and only local candidates will be considered.

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Posted: 2020-06-03 Expires: 2020-08-02

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Manufacturing Technician - Bioprocess

Genentech
South San Francisco, CA 94080

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