Manufacturing Operator II

TekWissen LLC; Fremont (CA); On-site; USD 30,000 - 39,000; Part time

Job summary

TekWissen Group is seeking a Manufacturing Operator II to support production operations at our Fremont site. You will operate and troubleshoot production equipment, ensure documentation accuracy, and help meet quality and throughput goals in a fast-paced environment.

Responsibilities include line preparation, material verification, batch records, and collaboration with Production Leads to drive process improvements and Lean initiatives.

Qualifications

• High school diploma or equivalent required.
• Minimum of 1 year of manufacturing, production, operations, laboratory, or related experience.
• Proficiency in Microsoft Word and Excel.
• Experience using QAD and Oracle systems.
• Knowledge of Good Documentation Practices (GDP).
• Strong written and spoken English communication.
• Ability to read and interpret SOPs, work instructions, safety guidelines and production documents.
• Able to lift up to 50 lbs and stand for extended periods.
• Experience with Lean manufacturing and process improvements.
• Experience in a cGMP manufacturing environment and Good Warehouse Practices.

Responsibilities

• Operate, set up, troubleshoot, and adjust production equipment under supervision.
• Manufacture and test products per cGMP and Quality System procedures.
• Maintain SOPs, work instructions, batch records, and production documentation.
• Read, verify materials, and prepare lines for manufacturing.
• Inspect materials and finished products throughout the process.
• Assist leads with job assignments and workflow coordination.
• Label, package, seal, and prepare finished products for shipment.
• Perform inventory transactions using QAD and other systems.
• Conduct line clearance, material reconciliation, and disposal.

Skills

Manufacturing experience

English communication

Multitasking

Problem solving

Organization

Lean manufacturing

SOP interpretation

GDP knowledge

cGMP knowledge

Good Warehouse Practices (GWP)

Direct machine operation

Process improvements

Education

High school diploma or equivalent

Tools

QAD

Oracle

Microsoft Word

Microsoft Excel

Job description

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.

Position:

Manufacturing Operator II

Location:

Fremont, CA 94538

Duration:

12 Months

Job Type:

Temporary Assignment

Work Type:

Onsite

Shift:

Monday to Friday from 06:00 AM 02:45 PM

Note:

Must be flexible to work overtime, weekends, staggered shifts (09:00 AM 05:45 PM), and swing shifts (04:00 PM 4:00 AM) based on business needs.

Summary

The Manufacturing Operator II is responsible for supporting manufacturing operations by operating production equipment, completing production documentation, ensuring product quality, and maintaining compliance with cGMP and Quality System requirements. This role works closely with production leads and supervisors to meet production goals while supporting continuous improvement initiatives in a fast-paced manufacturing environment.

Responsibilities

• Operate, set up, troubleshoot, and adjust production equipment under the direction of Production Leads or Supervisors.
• Manufacture and/or test products in accordance with cGMP requirements and Quality System procedures.
• Review, complete, and maintain SOPs, work instructions, batch records, and production documentation accurately.
• Read and interpret work orders, verify materials, and prepare production lines for manufacturing.
• Inspect raw materials and finished products throughout the manufacturing process.
• Assist Production Leads with job assignments and workflow coordination.
• Label, package, seal, and prepare finished products for shipment.
• Perform inventory and material transactions using QAD and other electronic management systems.
• Conduct line clearance activities, including material reconciliation and disposal.
• Clean and sanitize production equipment, workstations, and printers.
• Collaborate with production teams to resolve scheduling, equipment, and process issues.
• Support engineering activities related to process improvements and equipment validation.
• Participate in Lean Manufacturing, 5S, and Practical Process Improvement (PPI) initiatives.
• Follow all safety procedures and wear required Personal Protective Equipment (PPE).
• Perform additional production-related duties as assigned.

Required Skills

• High school diploma or equivalent required.
• Minimum of 1 year of manufacturing, production, operations, laboratory, or related experience.
• Knowledge of Microsoft Word and Excel.
• Ability to use electronic systems such as QAD and Oracle.
• Strong understanding of Good Documentation Practices (GDP).
• Excellent verbal and written English communication skills.
• Ability to read and interpret SOPs, work instructions, safety guidelines, and production documents.
• Basic mathematical skills.
• Strong organization, multitasking, and problem-solving abilities.
• Ability to work effectively in a collaborative team environment.
• Experience working in a cGMP manufacturing environment.
• Knowledge of Good Warehouse Practices (GWP).
• Direct machine operation experience.
• Experience supporting process improvements and Lean manufacturing initiatives.
• Ability to lift up to 50 lbs without assistance.
• Ability to stand for extended periods throughout the shift.
• May work in cold environments (as low as -20 C) and around loud manufacturing equipment.
• Required to wear PPE including steel-toe shoes, gloves, lab coats, safety glasses, and hearing protection.
• Position involves handling controlled substances (Schedules I V) in compliance with DEA, FDA, and company regulations.
• Successful completion of a background check, including controlled substance screening, is required.

TekWissen Group is an equal opportunity employer supporting workforce diversity.