Sterile Operations Lead: Aseptic Process & Compliance

Staffmark; San Diego (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Staffmark seeks an experienced Aseptic Process Manager to lead sterile manufacturing operations in San Diego, CA. You will supervise daily aseptic filling, capping, and lyophilization within classified cleanrooms, ensuring sterility, quality, and regulatory compliance.

The ideal candidate has strong aseptic filling/sterile operations background with cGMP/FDA knowledge, SOP development, and process validation expertise.

Qualifications

• Bachelor's degree in microbiology, bioengineering or related Life Science field.
• Minimum of 3 years in aseptic filling and sterile operations.
• Knowledge of cGMP and FDA regulations.
• Familiarity with lab procedures, solutions, chemicals, and reagents.
• Ability to pass aseptic gowning qualification and work in a cleanroom.
• Strong technical writing and communication skills.
• Proficiency with Word, Excel, Outlook; EDMS knowledge.
• Ability to adapt to changing project priorities while maintaining quality, safety, compliance.

Responsibilities

• Lead daily filling, capping, and lyophilization operations in classified cleanrooms.
• Ensure ISO 5/Class 100 standards and environmental monitoring compliance.
• Design and oversee aseptic process simulations (media fills).
• Collaborate with Engineering on IQ/OQ/PQ for aseptic filling lines, autoclaves, and depyrogenation tunnels.
• Manage SIP/CIP validation and execution.
• Lead investigations into environmental monitoring excursions and equipment failures.
• Develop and refine SOPs for sterile interventions and cleanroom practices.
• Oversee gowning and aseptic qualification programs for production staff.
• Support batch records, validation protocols, and cGMP documentation.
• Mentor operators and guide cross-functional teams to meet manufacturing goals.

Skills

Aseptic filling

Sterile operations

Regulatory compliance (cGMP/FDA)

Technical writing

Microsoft Word/Excel/Outlook

Electronic document management systems

Gowning qualification

Cleanroom operations

Education

Bachelor's degree in Microbiology, Bioengineering, or related Life Science field

Tools

Electronic document management systems

Job description

Staffmark seeks an experienced Aseptic Process Manager to lead sterile manufacturing operations in San Diego, CA. You will supervise daily aseptic filling, capping, and lyophilization within classified cleanrooms, ensuring sterility, quality, and regulatory compliance.

The ideal candidate has strong aseptic filling/sterile operations background with cGMP/FDA knowledge, SOP development, and process validation expertise.