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Sterile Manufacturing Associate

Job in San Jose, Santa Clara County, California, 95199, USA
Listing for: Frey Consulting Group
Full Time position
Listed on 2026-08-27
Job specializations:
  • Manufacturing / Production
    Pharmaceutical Manufacturing, Production QC/QA, Manufacturing & Industrial Operations
Salary/Wage Range or Industry Benchmark: 70000 - 95000 USD Yearly USD 70000.00 95000.00 YEAR
Job Description & How to Apply Below

We are seeking experienced Sterile Manufacturing Associates to join our growing team. This is a hands‑on role for individuals with cleanroom and aseptic manufacturing experience who understand the importance of precision, quality, and contamination control.

The ideal candidate has experience working in a sterile manufacturing environment and is comfortable following strict procedures, wearing full cleanroom attire, and spending the majority of the shift on their feet.

What You’ll Do
  • Perform sterile and aseptic manufacturing activities in a controlled cleanroom environment
  • Follow aseptic techniques and established procedures to maintain sterility and prevent contamination
  • Perform work within Biological Safety Cabinets (BSCs) and other controlled environments
  • Support sterile filling and related manufacturing processes
  • Follow SOPs, batch records, and cGMP requirements
  • Complete accurate documentation and maintain detailed production records
  • Identify, report, and document deviations, errors, and quality concerns
  • Maintain compliance with gowning, cleanliness, and contamination-control procedures
  • Support continuous improvement and other manufacturing activities as needed
What We’re Looking For
Required Qualifications:
  • Experience in sterile or aseptic manufacturing preferred
  • Experience working in a cleanroom environment, including ISO 5, ISO 7, Grade A, Grade B, Class 100, or similar classifications
  • Experience with full cleanroom gowning
  • Hands‑on experience using aseptic technique
  • Experience working in a Biological Safety Cabinet (BSC) preferred
  • Direct sterile filling experience strongly preferred
  • Experience following SOPs, batch records, and cGMP requirements
  • Strong understanding of contamination prevention and sterility requirements
  • Ability to accurately document work, deviations, and errors
  • Ability to follow detailed processes and work with a high level of accuracy and attention to detail
Physical Requirements
  • Must be comfortable wearing a full white cleanroom suit and required PPE
  • Ability to stand and work on your feet for up to 8 hours per day
  • Ability to work in a controlled cleanroom environment while following strict gowning and sanitation procedures
Ideal Background

The strongest candidates will have direct experience in an ISO 5 / Grade A / Class 100 environment
, including:

  • Full cleanroom gowning
  • Aseptic technique
  • Working inside a Biological Safety Cabinet

Candidates with meaningful ISO 7 or Grade B cleanroom experience and hands‑on aseptic technique are also encouraged to apply. Training may be available for individuals with transferable sterile or aseptic manufacturing experience.

If you have cleanroom or aseptic manufacturing experience and are looking for an opportunity to grow your skills in a highly regulated environment, we encourage you to apply!

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Position Requirements
10+ Years work experience
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