1+ months

Manufacturing Technician BioProcess (Contractor)

Vacaville, CA 95688

As a Manufacturing Technician, you will be responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in a current Good Manufacturing Practices (cGMP) environment. You will maintain areas in a high state of inspection preparedness and will utilize business systems for inventory and process management. You will maintain records to comply with regulatory requirements utilizing cGMP and Standard Operating Procedures (SOPs) and will 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.

Additionally, you will be accountable to:

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 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

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 SOPs and Manufacturing Formula is desirable

Must be able to 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

Please note: This job posting is a sourcing requisition. All applications received on this job posting will be reviewed by the onsite Talent Partner in Vacaville and candidates will be considered for both full-time regular AND contingent worker (temporary assignment) positions.

Work Shifts: Our manufacturing production facility operates 24/7. You must be able to work all of the shifts listed below. At the time of hire, you will assigned to a specific shift.

  • Front Swing Sun-Wed 16:00-2:30
  • Front Swing Mon-Fri 6:00-14:30
  • Back Swing Thu-Sat 13:30-2:30
  • Front Swing Sun-Wed 16:00-2:30
  • Back Swing Thu-Sat 6:00-19:00
  • Front Days Sun-Wed 6:00-16:30
  • Back Days Thu-Sat 6:00-16:30



Posted: 2020-05-07 Expires: 2021-04-23

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Manufacturing Technician BioProcess (Contractor)

Vacaville, CA 95688

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