Manufacturing Technician

TekWissen • Vacaville, CA

8d • Onsite

About The Position

The Manufacturing Technician supports the production of biotherapeutic medicines in a regulated cGMP manufacturing environment. The role involves operating automated manufacturing equipment, preparing materials, cleaning and sterilizing equipment, maintaining accurate production records, and following established safety and quality procedures. Technicians work in either Upstream or Downstream Manufacturing to support production activities and manufacturing schedules.

Requirements

• High school diploma or GED.
• Ability to follow detailed procedures and work effectively in a highly regulated, fast-paced manufacturing environment.
• Strong attention to detail and accurate documentation skills.
• Basic computer skills and ability to interact with automated manufacturing systems.
• Good problem-solving skills and ability to identify and escalate equipment, process, and quality issues.
• Strong communication, teamwork, reliability, and organizational skills.
• Commitment to safety, quality, and compliance with established procedures.
• Ability to meet physical requirements, including prolonged standing and walking, stair climbing, lifting and carrying materials, and repetitive bending and reaching.
• Ability to work weekends, off-shifts, and overtime as required.
• Availability for the initial two-week daytime training schedule, Monday through Friday, 8:00 AM–5:00 PM, before transitioning to the assigned permanent shift.
• Ability to comply with cleanroom requirements, including gowning procedures and restrictions on makeup and jewelry.

Nice To Haves

• Technical education, certification, or advanced college coursework.
• Mechanical aptitude or hands-on experience with equipment, machinery, or manufacturing processes.

Responsibilities

• Operate automated manufacturing equipment and process systems to support biotherapeutic production.
• Perform applicable upstream manufacturing activities, including media preparation, fermentation, harvest, seed train operations, and component dispensing.
• Perform applicable downstream manufacturing activities, including buffer preparation, filtration, fixed-tank operations, and column chromatography.
• Clean, sterilize, assemble, and prepare tanks, filtration systems, and other equipment for production.
• Prepare, dispense, and handle raw materials, components, and chemicals according to established procedures.
• Maintain accurate and complete manufacturing records, including production tickets, labels, equipment readings, and related documentation.
• Follow cGMP requirements, Standard Operating Procedures (SOPs), and applicable quality and regulatory guidelines.
• Monitor manufacturing processes and promptly report equipment malfunctions, process deviations, safety incidents, and quality concerns.
• Support production schedules by collaborating with manufacturing team members and helping resolve operational issues.
• Maintain cleanroom standards by following gowning procedures and using required personal protective equipment (PPE).
• Follow safety and environmental procedures when working with hazardous materials, chemicals, and pressurized equipment.
• Complete required training and maintain compliance with manufacturing and safety requirements.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED