Job Title: Manufacturing Associate
Location: Novato, CA
Hours/Schedule: Alternating Saturdays, Sunday–Tuesday, 6:00 PM – 7:00 AM
Compensation: $25-28/hr depending on qualifications
Type: 6 month contract

Overview

The Manufacturing Associate supports commercial bioprocess manufacturing operations, ensuring safe, compliant, and efficient production of bulk drug substances. This role operates and monitors manufacturing equipment, executes process steps, and contributes to continuous improvement initiatives while maintaining adherence to cGMP standards.

Responsibilities

• Operate and support biopharmaceutical manufacturing processes including mammalian cell culture, filtration, chromatography, centrifugation, purification, and bulk drug formulation.

• Monitor process performance and identify issues, escalating concerns and supporting resolution to maintain production continuity.

• Execute manufacturing steps according to standard operating procedures and batch records in a cGMP-regulated environment.

• Provide feedback on operational procedures and support updates to incorporate new technologies, standards, and best practices.

• Write and review technical and process documentation as required.

• Utilize quality systems to document and address deviations, CAPAs, change controls, and related compliance activities.

• Support process optimization initiatives and departmental performance metrics.

• Gain working knowledge of manufacturing automation and data systems such as LIMS, MES, and PI.

• Participate in cross-functional projects and support implementation of business systems such as TrackWise and ERP platforms.

Qualifications

• Bachelor’s degree in a science or engineering discipline or

• Associate’s degree in a science-related field or biotech certificate with 2+ years of experience in biotech manufacturing or another regulated industry.

• Experience working in cGMP-regulated manufacturing environments.

• Understanding of biopharmaceutical manufacturing processes such as cell culture, filtration, chromatography, or protein purification.

• Ability to write and review technical documentation and operational procedures.

• Experience working with quality systems such as deviations, CAPAs, and change controls.

Benefits

System One, and its subsidiaries including Joulé, ALTA IT Services, 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.