Manufacturing Associate Technician

Genentech

1d•Onsite

About The Position

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The position is located in Oceanside, On-site. The schedule could include a rotating (10-12 hour shift), one weekend day, evening or night hours, or full off-shift hours. In this dynamic role, you will be responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment, and maintaining areas in high state of inspection preparedness. Responsibilities include: Training and Compliance: Provide coaching and training on best practices and compliance with Standard Operating Procedures (SOPs). Understand the theory, concepts, and regulations behind biopharma technology and processes. Production and Equipment Operation: Prepare solutions for the production process. Operate systems that clean and sterilize tanks and filtration systems. Operate automated systems for equipment operation and assemble/prepare equipment for production. Continuous Improvement and Troubleshooting: Participate in continuous operational improvement. Troubleshoot equipment and process issues and work with coworkers and supervisors for effective solutions. Documentation and Safety: Review documentation and check all calculations (e.g., tickets, labels, equipment readings). Comply with safety requirements, Good Manufacturing Practices (cGMP), SOP, and manufacturing documentation. Support and Reporting: Provide support to Manufacturing to meet production demands. Provide reports to management summarizing goal unit attainment and anticipate potential problems, taking preventative action as necessary. Supplementary Responsibilities Operate fermenters, centrifuges, other harvest systems and protein purifications units. Operate and clean fixed tank and filtration systems. Operate large scale column chromatography systems. Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations. Perform Solution Preparation activities (media and buffer make-up). Clean, assemble, and sterilize equipment using glass washers and autoclaves. Perform automated CIP and SIP of fixed equipment.

Requirements

You have a degree in Life Sciences or Engineering and 1 year related experience, or Associate degree and 3 years experience, or High school and 5 years experience.
You have a Biotech certificate from approved program.
Expected to be on feet for 8 to 11 hours a day.
May climb upwards of 6 flights of stairs a day to maneuver within the manufacturing facility
Lifting up to 25lbs may be required.
Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
May work with hazardous materials and chemicals.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt.

Responsibilities

Provide coaching and training on best practices and compliance with Standard Operating Procedures (SOPs).
Understand the theory, concepts, and regulations behind biopharma technology and processes.
Prepare solutions for the production process.
Operate systems that clean and sterilize tanks and filtration systems.
Operate automated systems for equipment operation and assemble/prepare equipment for production.
Participate in continuous operational improvement.
Troubleshoot equipment and process issues and work with coworkers and supervisors for effective solutions.
Review documentation and check all calculations (e.g., tickets, labels, equipment readings).
Comply with safety requirements, Good Manufacturing Practices (cGMP), SOP, and manufacturing documentation.
Provide support to Manufacturing to meet production demands.
Provide reports to management summarizing goal unit attainment and anticipate potential problems, taking preventative action as necessary.
Operate fermenters, centrifuges, other harvest systems and protein purifications units.
Operate and clean fixed tank and filtration systems.
Operate large scale column chromatography systems.
Operate small-scale cell culture areas and systems by operating cleaning, set up, and maintaining 20L batch feed fermenters; inoculating and maintaining spinner seed cultures using aseptic techniques, maintaining cell banks; and performing general seed lab operations.
Perform Solution Preparation activities (media and buffer make-up).
Clean, assemble, and sterilize equipment using glass washers and autoclaves.
Perform automated CIP and SIP of fixed equipment.