Manufacturing Associate I/II - Upstream

Actalent • Vacaville, CA • 1w ago

Hiring a Manufacturing Associate II for a great Biomanufacturing Lab in Vacaville, CA! Must have experience with upstream manufacturing processes, fermentation, cell culture, media prep, and more. Schedule: M-F day shift Role Summary

The Manufacturing Associate II (Upstream) supports the production of drug products and intermediates by following approved procedures and maintaining compliance with cGMP and GDP standards. This role requires completion of quality system and production training, as well as qualification for aseptic gowning to work in a cleanroom environment.

Key Responsibilities

Participate in upstream manufacturing processes, including fermentation, cell culture, cell separation, cell lysis, and media preparation.

Operate, clean, and store processing equipment.

Collect and submit cleaning and in-process samples to Quality Control.

Sterilize manufacturing parts and manage raw material inventory.

Execute process development and validation protocols as needed.

Perform inventory cycle counts and fit-for-use inspections.

Draft and revise SOPs, batch records, and protocols under change control.

Initiate and investigate deviations, and support resolution and CAPA implementation.

Collaborate with cross-functional teams including Quality Control, Facilities, MSAT, and Quality Assurance.

Required Skills & Qualifications

Experience with large-scale upstream manufacturing processes.

Strong understanding of cGMP and GDP compliance.

Ability to work independently with minimal supervision.

Proficiency in Microsoft Word, Excel, Teams, and other organizational tools.

Excellent written and verbal communication skills.

Strong organizational and record-keeping abilities.

Previous experience in a cleanroom environment and aseptic gowning is preferred.

Familiarity with deviation management and CAPA processes.

Top Skills

Quality Systems

GMP Compliance

Upstream Manufacturing

CAPA

Cleanroom Operations

SOP Documentation

Cell Culture & Media Prep

Pay and Benefits

The pay range for this position is $30.00 - $36.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Vacaville,CA.

Application Deadline

This position is anticipated to close on Sep 30, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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