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Vacaville, California Ascent
Job Information:
Title: Manufacturing Bioprocess Technician
Pay Rate: $22.00
Start Date: 10/05/2020
End Date: 10/05/2023
Position Type: Contract
Location: Vacaville, CA, United States

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 be assigned to a specific shift.
Upstream Days: Front: Sunday Tuesday (SWD)
Back: Thursday Saturday (WSD)
06:00 AM 19:00 (7:00 PM) 12 hour shift with 1 hour lunch
Upstream Graves: Front: Sunday Tuesday (STG)
Back: Wednesday Friday (WSG)
18:00 (6:00 PM) 07:00 AM 12 hour shift with 1 hour lunch
Downstream Days: Front: Sunday Tuesday (SWD)
Back: Thursday Saturday (WSD)
06:30 AM 19:30 (7:30 PM) 12 hour shift with 1 hour lunch
Downstream Graves: Front: Sunday Tuesday (STG)
Back: Wednesday Friday (WSG)
18:30 (6:30 PM) 07:30 AM 12 hour shift with 1 hour lunch
Production Services:
1. Monday Friday 5 x 8
a. 06:00 AM 14:30 (2:30 PM) Days Only/Weight & Dispense Only
2. Sunday Wednesday - 4 x 10
a. 06:00 AM 16:30 (4:30 PM) Days
b. 16:00 (4:00 PM) 02:30 AM Nights
3. Thursday Saturday 3 x 12 (36 hours/week)
a. 06:00 AM 19:00 (7:00 PM) Days
b. 13:30 (1:30 PM) 02:30 AM Nights

10% shift differential for graveyard
  • 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

Skills:
  • 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
  • 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.

Education:

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

Department:
152 : Downstream CCP2
Operations Functs : VV Shared Services : Vaca Manufacturing CCP2 : Vaca Manufacturing CCP2

Job Category:
Manufacturing

Hours Per Week:
40.00

Is this contractor working in a GMP environment?:
Yes