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Job description
Bio-Therapeutic Medicine Production SpecialistResponsible 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. 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 in a team environment.Shift Restriction Note: Candidates must be fully available to work the designated day-shift hours during the initial 2-week training period before transitioning to the permanent night shift.Qualifications: High School Diploma or GED. Motivated individuals with a mechanical background/hands-on experience looking to transition into a new industry. Current college students (Junior, Technical, or Community College) looking for a stable night shift. Some advanced college-level coursework or a technical degree/certification is highly preferred.Key Competencies: Compliance & Process-Oriented: Must be able to thrive in a highly regulated, fast-paced environment. We are looking for individuals who strictly follow established standard operating procedures (SOPs) and prioritize compliance over "improvising" or trying to solve complex process steps without guidance. Resilience & Problem Solving: Ability to adapt and maintain a strong work ethic when facing operational challenges.Work Environment/Physical Demands/Safety Considerations 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
Worksite address
vacaville, CA, 95687, US
Who can apply
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