1+ months

Manufacturing Technician, Downstream Operations CCP2

Vacaville, CA 95688

Please note there are multiple positions on either Day or Night Shift

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, weve become one of the worlds leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients lives. We are courageous in both decision and action, we believe that good business means a better world.

The focus of the Vacaville Operations Facility is Drug Substance bulk manufacturing team. We have a passion for science, technology, innovation, professional development, and diversity and inclusion. We are also deeply respected for our unique and special culture; one that centers around the people we attract and hire. Beyond the intellect, people are kind and giving. Employees volunteer their time to help each other learn new skills, and give of themselves to the larger community. Our Pharma vision is to have a greater overall patient benefit and impact. This focus includes personalized healthcare, designing the processes with the patient in mind, and improving their quality of life. We hope you consider joining our team and being a part of one of the largest biotechnology facilitiesin the world!

Responsible for producing innovative bio-therapeutic 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:

Upstream Manufacturing (UM): Primary focus is the cleaning, sterilization and operation of fixed vessel systems for media preparation, fermentation, and harvest operations; perform seed train operations; perform dispensing of components; handle and aliquot hazardous materials.

Downstream Manufacturing (DM): 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; perform dispensing of components; handle and aliquot hazardous materials.

Production Services (PS): Provide support to Manufacturing 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 and Kanban, glassware, parts and equipment; perform weighing and kitting of components; handle and aliquot hazardous materials; Provide quality materials and service to our customers.

Manufacturing Technician Level

  • Follow 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 safe work practices

  • Operate systems that clean and sterilize tanks and filtration systems.

  • Prepare materials for the production process.

  • Exhibit detail oriented documentation skills to ensure Right-First-Time operations (e.g. tickets, labels, equipment reading)

  • Escalate process issues as necessary to ensure resolution of issue

  • Comply with cGMP, SOP and manufacturing documentation.

  • Use automation to perform production and equipment operations.

  • Provide support to Manufacturing to meet production demands.

  • Assemble and prepare equipment for production.

  • Communicate effectively and professionally work in a team environment.

Senior Technician Level - all Technician responsibilities, plus

  • Be able to perform all routine operations

  • Train other technicians in group and individual settings

  • Troubleshoot process equipment and systems

Master Technician Level - all Senior Technician responsibilities, plus

  • Serve as an example and advocate of ingrained quality

  • Champion safety improvements and encourages safe work practices in department

  • Contribute to a LEAN work environment by acting as a change agent and utilizing OE Tools

  • Contribute to the improvement of training material and practices

  • Serve as department representative on cross-functional teams

  • Demonstrate Roche Leadership Competencies within Department and to the site

  • Be able to act as SME to regulatory agencies

  • Lead troubleshooting efforts to resolve complex process issues

Job Requirements

Education and Experience

  • Required: High School Diploma

  • Desirable but not required: 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 Formula is desirable.

Work Environment/Physical Demands/Safety Considerations

  • Must be able work weekends, off-shifts, and overtime as required.

  • No make-up or jewelry can be worn when working in the clean room environment.

  • Work on and around pressurized tanks, housings and equipment, which are connected by piping and pumps and services by pressurized steam, water, air and cleaning/sanitizing chemicals systems.

  • Don gowning in the form of hospital scrubs, coveralls and safety toe footwear with shoe covers being multiple times per shift.

  • Don lab coats as well as safety glass/goggles, gloves (nitrile or latex) multiple times per shift.

  • Handle and work with hazardous materials and chemicals per OSHA guidelines.

  • Usage of hearing protection and dust masks may be required.

  • Expected to be on feet standing or walking for up to 90% of shift.

  • Travel up to 30 flights of stairs each shift to maneuver within the facility.

  • Utilize keyboard and mouse to interact with process automation systems as well as email, word processing/spreadsheets and other online computer systems.

  • Lift up to 40lb(18.2kg) loads multiple times per shift and carry up to 30 lbs(13.6kg). Team lifting will be used for heavier or awkward lifts/carries up to 20 times per shift.

  • Push or pull materials with up to 50lb-force with full body. Utilize mechanical means or powered industrial trucks for forces beyond the 50lb-force limit up to 10 times per shift.

  • Manipulation of process equipment, connections and raw materials may require bending and reaching as well as repetitive twisting gripping hand motions. Where mechanical stress or pressure can be transmitted to the palm and the fingers during hand tool use, especially when large forces must be exerted. Forces should not exceed 22 pounds/inch2 (10 kg/cm2).

  • In order to operate powered industrial trucks, employee must pass a DOT Physical which includes: Blood Pressure <140/90, Vision must be at least 20/40 in both eyes with or without corrective lenses, pass color vision and whisper hearing test as well as have a valid Drivers License

Roche is an equal opportunity employer.





Posted: 2021-06-18 Expires: 2021-08-18

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Manufacturing Technician, Downstream Operations CCP2

Vacaville, CA 95688

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