["Manufacturing Technician I","Manufacturing Technician I"]

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps its customers deliver new and innovative medicines that help treat a wide range of diseases. Our client 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.

Job Title: Manufacturing Technician I
Location: Vacaville, CA 95688
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Regular Shift: Back Half Nights, Wednesday - Friday, with alternating Saturdays, 6:00 PM - 7:00 AM (approx. 13-hour shifts)
Training Schedule: Please note that the first 2 weeks require a daytime training shift: Monday - Friday, 8:00 AM - 5:00 PM.

Summary:

Responsible for producing innovative bio-therapeutic medicine by interfacing with highly automated production systems and controls in a cGMP manufacturing environment. Maintain production areas in a high state of inspection preparedness and utilize business systems for inventory and process management. Maintain records to comply with regulatory requirements using current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). Participate in the routine production of mammalian cell culture products within the manufacturing facility in one or more of the areas, Primary focus is the cleaning, sterilization, and operation of fixed vessel systems for media preparation, fermentation, and harvest operations. Perform seed train operations, dispense components, and handle and aliquot hazardous materials.Operate and clean fixed tank systems and filtration systems, perform large-scale buffer preparation, operate column chromatography systems, dispense components, and handle and aliquot hazardous materials. 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, while fostering safe work practices.

Responsibilities:

• Operate systems that clean and sterilize tanks and filtration systems.
• Prepare materials for the production process.
• Maintain accurate and detail-oriented documentation to ensure Right-First-Time operations (tickets, labels, equipment readings).
• Escalate process issues as necessary to ensure timely resolution.
• Comply with cGMP, SOPs, and manufacturing documentation requirements.
• Use automation systems to perform production and equipment operations.
• Provide support to manufacturing operations to meet production demands.
• Assemble and prepare equipment for production.
• Communicate effectively and professionally in a team environment.
• Work weekends, off-shifts, and overtime as required.
• Follow all clean room gowning and PPE requirements.
• Handle hazardous materials and chemicals in accordance with OSHA guidelines.
• Perform physical activities including prolonged standing, walking, lifting, carrying, pushing, pulling, bending, reaching, twisting, and operating process equipment.
• Utilize process automation systems, email, spreadsheets, and other computer systems.
• Operate powered industrial trucks after meeting DOT physical requirements and maintaining a valid driver's license.

Required Skills:

• High School Diploma or GED (minimum requirement).
• Advanced college-level coursework or a technical degree/certification preferred.
• Mechanical background or hands-on experience is welcomed.
• Ability to work in a highly regulated, fast-paced cGMP manufacturing environment.
• Strong understanding of and adherence to Standard Operating Procedures (SOPs) and compliance requirements.
• Detail-oriented documentation skills.
• Ability to adapt to operational challenges and maintain a strong work ethic.
• Effective communication and teamwork skills.
• Ability to work weekends, off-shifts, and overtime as required.
• Ability to perform the physical demands of the role, including standing or walking for up to 90% of the shift, climbing stairs, lifting and carrying materials, pushing and pulling loads, and working in a clean room environment while wearing required PPE.
• Ability to operate powered industrial trucks upon successful completion of required DOT physical examination and possession of a valid driver's license.

TekWissen® Group is an equal opportunity/affirmative action employer (m/f/d/v) supporting workforce diversity.