Manufacturing Technician, BioProcess
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
The Position
Summary:
Responsible for producing innovative biotherapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment; maintaining areas in high state of inspection preparedness, and utilizing business systems for inventory and process management. Maintain records to comply with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Participate in the routine production of mammalian cell culture products within the Vacaville Manufacturing Facility, operating in at least one of the following production areas:
- Cell Culture Manufacturing (CCM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations.
- Purification Operations Group (POG): Responsibilities include the operation and cleaning of fixed tank systems, the operation and cleaning of filtration systems, large-scale buffer preparation, and the operation of column chromatography systems.
- Centralized Manufacturing Services (CMS): Provide support to Manufacturing and Quality Control to meet production demands. Duties include but are not limited to: CIP/SIP of portable and Freeze/Thaw tanks; clean, assemble, and autoclave 20L fermenters; prepare and autoclave manufacturing assemblies; autoclave solutions; clean, kanban, and deliver lab ware, glassware, parts and equipment; perform weighing and dispensing of components; handle and aliquot hazardous materials; Provide quality materials and service to our customers.
Job Responsibilities:
- 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.
- 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).
- Trouble shoot equipment and process problems.
- Comply with safety requirements, cGMP, SOP and manufacturing documentation.
- Use of 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.
- Exhibit detail oriented documentation skills.
- Communicate effectively and ability to work in a team environment.
- Exhibit professional interpersonal skills.
- Work with coworkers and supervisor to effectively troubleshoot minor equipment and process issues.
Who You Are
Education and Experience:
- AS//BS/BA in Biological Sciences, Physical Sciences, or Engineering
- Or combination of college coursework and related work experience
- Or Biotech certificate from approved program
Knowledge, Skills, and Abilities:
- Strong oral and written communication skills
- Familiarity of computer-based systems
- Ability to receive, interpret and provide basic information and materials involved with the day to day activities of performing the job
- Ability to read and understand engineering documents is desirable
- Experience in creation and revision of Standard Operating Procedures and Manufacturing Formulae is desirable
Work Environment/Physical Demands/Safety Considerations:
- Must be able work weekends, off-shifts, and overtime as required.
- Expected to be on feet for 8 to 10 hours a day.
- Lift up to 40lbs may be required.
- Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.
- No make up or jewelry can be worn when working in the clean room environment.
- Work in clean room environment with large mechanical and material handling equipment.
- Environment requires work in areas where piping and pumps are connected to tanks serviced by high-pressure steam, water and air, creating a load environment.
- Work with hazardous materials and chemicals.
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.
