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Manufacturing Technician - BioProcess

Vacaville
California, United States of America


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The Position

The Manufacturing Technician is responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in cGMP manufacturing environment. The individual will be required to work in and maintain a clean room environment. Area of work must remain in a high state of inspection readiness at all times. In addition, this individual will maintain 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). Work will involve 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.

Responsibilities

  • 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.
  • Be able to perform all routine operations
  • Train other technicians in group and individual settings
  • Troubleshoot process equipment and systems

Qualifications

  • Bachelor's degree preferably in Life Sciences or engineering, or Associate's degree and 1+ year of related experience, or High School diploma and 2+ years related experience. Biotech certificate from approved program desirable.
  • 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 Driver’s License 

This position is not eligible for relocation. Only local candidates will be considered.

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Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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