Sterile Manufacturing Associate

Frey Consulting Group; San Jose (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Frey Consulting Group in California seeks an experienced Sterile Manufacturing Associate to join our regulated production team. This hands-on role requires working in cleanrooms, donning full gowning, and adhering to strict aseptic procedures to ensure product sterility and quality.

You will perform sterile manufacturing activities, document deviations, and support cGMP compliance while maintaining rigorous quality records and safety standards.

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.

Responsibilities

• 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

Skills

Sterile manufacturing

Aseptic technique

Cleanroom gowning

Documentation accuracy

Attention to detail

Job description

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!