Manufacturing Operator

Job Title: Manufacturing Operator
Location: Fremont, CA
Type: Contract
Compensation: $20.00
Contractor Work Model: Onsite
Hours: 40.0

Overview
Leading pharmaceutical company looking for an experienced Manufacturing Operator. Ideal candidates should have at least High School diploma plus at least 1 year of work experience in a GMP regulated industry.

Responsibilities

• Execute routine unit operations in Manufacturing Assembly and Packaging related to drug product manufacturing in a multi-product facility.
• Assist in setting up automated autoinjector assembly machines, pre-filled syringe assembly machines, and semi-automated tabletop machines, including gathering tools, machine parts, and documents.
• Support equipment changeovers, minor repairs, and adjustments.
• Identify and troubleshoot mechanical and component issues in real-time, escalating as needed.
• Document all activities accurately in batch records, logbooks, or SOP attachments in accordance with SOPs.
• Assist with room cleaning, waste disposal, and sanitization of production areas following safety protocols.
• Verify equipment calibration and ensure proper use of equipment as per controlled documents.
• Perform assembly and packaging operations, including visual inspection and filling operations if required.
• Ensure components, materials, and supplies are stocked prior to operations.
• Manage movement of product, components, and equipment within the production area.
• Communicate shift changes and hand off responsibilities appropriately.
• Maintain production areas according to predefined standards (5S).
• Adhere to safety standards, report unsafe conditions, and escalate issues as necessary.

• High School diploma plus at least one (1) year of work experience in a GMP regulated industry.
• Basic reading, writing, and understanding of English.
• Ability to read and follow Standard Operating Procedures (SOP).
• Basic math skills including addition, subtraction, multiplication, and division.
• Experience with Good Documentation Practices (GDP).
• Basic computer skills, including email communication and Microsoft Office programs (Outlook, Internet Explorer/Edge).

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific