Manufacturing Associate – 3rd Shift | Fremont, CA | 4-Month Contract

Manufacturing Associate – 3rd Shift

Sigma Inc. is seeking a Manufacturing Associate for a 4-month onsite contract opportunity with our client in Fremont, CA. This position is ideal for candidates with experience in GMP manufacturing, pharmaceutical or biotechnology production, assembly, packaging, or other regulated manufacturing environments.

The Manufacturing Associate will execute routine manufacturing operations related to drug product assembly and packaging in a multi-product facility. The role requires strong attention to detail, adherence to cGMP, SOPs, batch records, safety procedures, and controlled documentation requirements, and the ability to work effectively on a 3rd shift production team.

• Execute routine manufacturing assembly and packaging operations as assigned.
• Assist Senior and Master Associates with assembly and packaging activities.
• Assist with setup of automated autoinjector assembly machines, pre-filled syringe assembly machines, and semi-automated tabletop machines.
• Gather tools, machine parts, documents, components, and equipment needed for production activities.
• Retrieve components and equipment from designated storage areas.
• Assist with equipment changeovers.
• Perform minor equipment repairs and adjustments as directed.
• Assist with real-time identification and correction of mechanical and component-related production issues.
• Follow all company policies, procedures, SOPs, and manufacturing instructions.
• Accurately document all activities in batch records, logbooks, SOP attachments, and other controlled documents.
• Record production events and escalate issues to the Production Supervisor for appropriate follow-up.
• Verify equipment calibration status and complete equipment logbooks as required.
• Perform assembly and packaging operations and assist with visual inspection and filling activities when needed.
• Ensure components, materials, and supplies are properly stocked before production begins.
• Move products, components, and equipment within designated assembly and packaging areas.
• Transfer product, components, and equipment within the CNC area.
• Complete effective communication and handoff to relief personnel during shift changes.
• Assist with production room cleaning and sanitization.
• Remove equipment and dispose of waste according to established safety requirements.
• Transfer waste to designated transfer zones as required.
• Maintain production areas according to established 5S standards.
• Follow proper manufacturing techniques and documentation practices.
• Identify unsafe conditions or behaviors and escalate them appropriately.

• High school diploma or GED required.
• High school diploma/GED plus at least 1 year of experience in a GMP-regulated industry.
• Experience in a pharmaceutical, biotechnology, medical device, or other regulated manufacturing environment strongly preferred.
• Associate or bachelor's degree from an accredited institution or biotechnology vocational training preferred.
• Ability to read, understand, and follow written instructions, SOPs, and controlled documents.
• Strong attention to detail and organizational skills.
• Demonstrated basic mathematical skills, including addition, subtraction, multiplication, division, and conversions.
• Strong written and verbal communication skills.
• Ability to work effectively in a small team environment.
• Basic computer proficiency, including Microsoft Office, Outlook, and other computer-based systems.
• Ability to maintain concentration and accuracy while performing repetitive manufacturing activities.
• Ability to stand and walk for extended periods in a manufacturing environment.
• Willingness and ability to work a 3rd shift schedule, Monday–Friday, 10:00 PM–6:30 AM.

Candidates with experience in the following areas are encouraged to apply:

• GMP / cGMP Manufacturing
• Pharmaceutical Manufacturing
• Biotechnology Manufacturing
• Drug Product Manufacturing
• Medical Device Manufacturing
• Manufacturing Associate
• Manufacturing Technician
• Production Associate
• Assembly & Packaging
• Autoinjector Assembly
• Pre-Filled Syringe Assembly
• Equipment Changeover
• Equipment Troubleshooting
• Batch Records
• SOPs
• Controlled Documentation
• Visual Inspection
• Filling Operations
• Cleanroom Manufacturing
• 5S / Lean Manufacturing
• Regulated Production