Manufacturing Associate

Manufacturing Technician I – Upstream/Downstream Manufacturing Shift & Training Schedule Regular Shift: • Back Days: Thursday–Saturday + every other Wednesday • Hours: 6:00 AM – 7:00 PM Training Schedule: • First 2 weeks: Monday–Friday • 8:00 AM – 5:00 PM Important: Candidates must be fully available for the daytime training schedule during the initial two weeks before transitioning to the permanent shift. Job Overview The Manufacturing Technician will support the production of innovative biotherapeutic medicines within a highly automated cGMP manufacturing environment at the Vacaville Manufacturing Facility. The role involves operating production systems and equipment, maintaining inspection readiness, managing materials and inventory, and completing accurate manufacturing documentation in compliance with cGMP and SOP requirements. Candidates should be detail-oriented, resilient, safety-conscious, and comfortable working in a highly regulated manufacturing environment. Key Responsibilities • Participate in routine production of mammalian cell culture products within the manufacturing facility. • Operate highly automated production systems and process controls. • Follow established cGMP, SOP, safety, and environmental procedures. • Maintain accurate manufacturing records and ensure Right-First-Time (RFT) documentation. • Prepare materials and equipment for production activities. • Operate systems used to clean and sterilize tanks and filtration systems. • Assemble and prepare equipment for manufacturing operations. • Escalate process or equipment issues as appropriate to ensure timely resolution. • Support Manufacturing operations to meet production schedules and demands. • Maintain manufacturing areas in a high state of inspection preparedness. • Utilize business and automation systems for inventory, process management, and production activities. • Communicate effectively and professionally within a team environment. • Immediately report safety and environmental incidents, injuries, illnesses, near misses, and safety concerns. • Promote and maintain safe work practices. Upstream Manufacturing (UM) Responsibilities may include: • Cleaning, sterilization, and operation of fixed vessel systems. • Media preparation and fermentation operations. • Harvest operations. • Seed train operations. • Dispensing of production components. • Handling and aliquoting hazardous materials. Downstream Manufacturing (DM) Responsibilities may include: • Operation and cleaning of fixed tank systems. • Operation and cleaning of filtration systems. • Large-scale buffer preparation. • Operation of column chromatography systems. • Dispensing of production components. • Handling and aliquoting hazardous materials. Required Qualifications • High School Diploma or GED required. • Advanced college-level coursework, technical education, or certification is highly preferred. • Hands-on or mechanical experience is welcomed. • Current Junior, Technical, or Community College students may be considered. • Ability to work effectively in a regulated, fast-paced manufacturing environment. • Strong attention to detail and ability to follow established procedures. • Ability to demonstrate resilience, adaptability, and a strong work ethic when facing operational challenges. Ideal Candidate Profile We welcome candidates from diverse backgrounds, including: • Individuals with mechanical, manufacturing, or hands-on technical experience looking to transition into biopharmaceutical manufacturing. • Candidates with experience in food service, warehouse, production, manufacturing, or other highly process-driven environments. • Candidates with military backgrounds, particularly those accustomed to following procedures, maintaining discipline, and working in team-oriented environments. • Current technical/community college students seeking stable manufacturing employment. Key Competencies Compliance & Process Orientation • Comfortable working in a highly regulated environment. • Strictly follows SOPs and established processes. • Prioritizes compliance and safety over improvisation. • Demonstrates strong documentation and attention-to-detail skills. Resilience & Problem Solving • Able to adapt to operational challenges. • Maintains productivity and professionalism under pressure. • Escalates issues appropriately rather than bypassing established procedures. Shift & Training Schedule Regular Shift: • Back Days: Thursday–Saturday + every other Wednesday • Hours: 6:00 AM – 7:00 PM Training Schedule: • First 2 weeks: Monday–Friday • 8:00 AM – 5:00 PM Important: Candidates must be fully available for the daytime training schedule during the initial two weeks before transitioning to the permanent shift. Work Environment & Physical Requirements • Must be willing to work weekends, off-shifts, and overtime as required. • Work in cleanroom/manufacturing environments. • No makeup or jewelry permitted in cleanroom areas. • Work around pressurized tanks, piping, pumps, steam, water, air, and cleaning/sanitizing chemicals. • Wear required scrubs/coveralls, safety-toe footwear, shoe covers, lab coats, safety glasses/goggles, and gloves. • Handle hazardous materials and chemicals according to OSHA guidelines. • Hearing protection and dust masks may be required. • Standing or walking for up to 90% of the shift. • Climb up to 30 flights of stairs per shift. • Operate computers, keyboards, mice, and automated manufacturing systems. • Lift loads up to 40 lbs multiple times per shift. • Carry loads up to 30 lbs. • Team lifting is required for heavier or awkward loads. • Push/pull materials using up to 50 lbs of force. • Perform bending, reaching, gripping, twisting, and repetitive hand movements as required for manufacturing operations. • Powered industrial truck operation requires passing a DOT physical and meeting applicable vision, hearing, color-vision, and driver's license requirements.