Manufacturing Associate

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions. Our client is a leading biotechnology company combining technological insight with world-class manufacturing, scientific expertise, and process excellence to help deliver new and innovative medicines for a wide range of diseases. The company specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

About the role

This is a 6-month temporary onsite assignment in Vacaville, CA. You will produce innovative biotherapeutic medicines by interfacing with highly automated production systems and controls in a cGMP manufacturing environment. The role maintains manufacturing areas in a high state of inspection preparedness while utilizing business systems for inventory and process management. You will participate in the routine production of mammalian cell culture products and may support either Upstream Manufacturing (UM) or Downstream Manufacturing (DM) operations.

Note: If selected, you must be fully available for the initial two-week training schedule, Monday–Friday, 8:00 AM–5:00 PM, before transitioning to the permanent schedule.

Schedule

Thursday to Saturday and every other Wednesday from 06:00 AM to 07:00 PM.

Pay

$25 to $28 per hour.

Responsibilities

• Operate systems used to clean and sterilize tanks, filtration systems, and other manufacturing equipment.
• Prepare materials and equipment for production processes.
• Assemble and prepare equipment for manufacturing operations.
• Use automated systems to perform production and equipment operations.
• Perform routine production activities within Upstream or Downstream Manufacturing.
• Support Upstream Manufacturing activities, including media preparation, fermentation, harvest operations, seed train operations, component dispensing, and handling/aliquoting of hazardous materials.
• Support Downstream Manufacturing activities, including fixed tank and filtration system operations, large-scale buffer preparation, column chromatography operations, component dispensing, and handling/aliquoting of hazardous materials.
• Exhibit strong attention to detail and documentation practices to ensure Right-First-Time operations, including completion of tickets, labels, and equipment readings.
• Comply with cGMP, SOPs, manufacturing documentation, and applicable regulatory requirements.
• Escalate process issues as necessary to ensure timely resolution.
• Provide support to Manufacturing to meet production demands.
• Follow established safety and environmental guidelines and procedures.
• Immediately report safety and environmental incidents, including injuries, illnesses, near misses, and safety suggestions.
• Foster and maintain safe work practices.
• Communicate effectively and professionally within a team environment.
• Maintain areas in a high state of inspection preparedness.
• Utilize business systems for inventory and process management.
• Work with process equipment, piping, pumps, pressurized tanks, filtration systems, steam, water, air, and cleaning/sanitizing chemical systems.
• Follow OSHA guidelines when handling hazardous materials and chemicals.
• Work weekends, off-shifts, and overtime as required.
• Complete required gowning procedures and wear appropriate PPE in cleanroom and manufacturing environments.
• Utilize computers, process automation systems, email, word processing, spreadsheets, and other online systems.
• Perform physical activities including standing/walking for extended periods, climbing stairs, lifting, carrying, pushing, pulling, bending, reaching, and repetitive gripping/twisting motions.
• Team lift heavier or awkward materials as required.
• Operate powered industrial trucks when qualified and when required for the position.

Requirements

• High School Diploma or GED required.
• Advanced college-level coursework or a technical degree/certification preferred.
• Ability to work effectively in a highly regulated, fast-paced manufacturing environment.
• Strong compliance and process-oriented mindset.
• Ability to strictly follow established SOPs and manufacturing procedures without independently improvising controlled process steps.
• Strong attention to detail and documentation skills.
• Ability to maintain Right-First-Time documentation and operations.
• Ability to adapt to operational challenges and demonstrate resilience.
• Strong problem-solving and issue-escalation skills.
• Ability to communicate effectively and professionally in a team environment.
• Ability to work with automated manufacturing and process control systems.
• Ability to work safely around hazardous materials, chemicals, pressurized equipment, and manufacturing systems.
• Ability to work weekends, off-shifts, and overtime as required.
• Ability to complete cleanroom gowning requirements and wear required PPE.
• Ability to meet the physical demands of the manufacturing environment, including:
  • Standing/walking for up to 90% of the shift.
  • Climbing up to 30 flights of stairs per shift.
  • Lifting up to 40 lb.
  • Carrying up to 30 lb.
  • Pushing/pulling materials as required.
• Ability to operate powered industrial trucks, if required, including meeting applicable physical, vision, hearing, color-vision, and driver's license requirements.