Job Description
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 Associate
Location: Vacaville, CA 95688
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Thursday to Saturday and every other Wednesday from 06:00 AM to 07:00 PM
Location: Vacaville, CA 95688
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Thursday to Saturday and every other Wednesday from 06:00 AM to 07:00 PM
Note: If selected, 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.
Summary:
Responsible for producing innovative biotherapeutic medicines by interfacing with highly automated production systems and controls in a cGMP manufacturing environment. Maintains manufacturing areas in a high state of inspection preparedness while utilizing business systems for inventory and process management. Maintains accurate records in compliance with regulatory requirements, cGMP, and SOPs. Participates in the routine production of mammalian cell culture products within the manufacturing facility and may support either Upstream Manufacturing (UM) or Downstream Manufacturing (DM) operations. Follows established safety and environmental procedures, supports production demands, and works effectively in a team-oriented manufacturing environment.
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.
Required Skills:
- 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, and 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.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Vacaville, CA |
| Industry | Computer/IT Services |
| Salary | $25–$28 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Agricultureunmatched
- Automation Systemsunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Business Solutionsunmatched
- Cell Culturesunmatched
- Cleanroomunmatched
- Column Chromatographyunmatched
- Communication Skillsunmatched
- Control Systemsunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Customer Support/Serviceunmatched
- Detail Orientedunmatched
- Diseaseunmatched
- Documentationunmatched
- Driver's Licenseunmatched
- Email Softwareunmatched
- Gene Therapyunmatched
- Hazardous Materials/Substancesunmatched
- High School Diplomaunmatched
- Higher Educationunmatched
- Inventory Managementunmatched
- Large-Scale Systemsunmatched
- Lift/Move 30 Poundsunmatched
- Lift/Move 40 Poundsunmatched
- Manufacturingunmatched
- Manufacturing Equipmentunmatched
- Manufacturing Operationsunmatched
- Manufacturing Systemsunmatched
- Manufacturing/Industrial Processesunmatched
- Material Scienceunmatched
- Medical Productsunmatched
- Nutritionunmatched
- OSHAunmatched
- Personal Careunmatched
- Physical Demandsunmatched
- Pipingunmatched
- Problem Solving Skillsunmatched
- Process Control Engineeringunmatched
- Process Managementunmatched
- Production Controlunmatched
- Production Supportunmatched
- Production Systemsunmatched
- Pumpsunmatched
- Record Keepingunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Safety Processunmatched
- Safety/Work Safetyunmatched
- Spreadsheetsunmatched
- Standard Operating Procedures (SOP)unmatched
- System Operationsunmatched
- Team Playerunmatched
- Time Managementunmatched
- Word Processingunmatched
- Workforce Managementunmatched
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