Aseptic Operations Lead – Sterile Fill/Finish

Staffmark Group; San Diego (CA); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Life insurance

Disability insurance

401(k)

Paid time off (PTO)

Job summary

Staffmark is hiring an Aseptic Process Manager in San Diego, CA to lead sterile manufacturing operations. You will ensure absolute sterility, oversee daily filling, capping, and lyophilization, and maintain ISO 5 conditions while adhering to global regulatory requirements.

This role partners with Engineering on IQ/OQ/PQ, oversees SIP/CIP, mentors operators, and supports essential documentation (MBRs/EBRs). A Life Sciences degree and 3+ years in aseptic filling are required; salary

Qualifications

• Bachelor's degree in Microbiology, Bioengineering, or related Life Science field.
• 3+ years of experience specifically in aseptic filling and sterile operations.
• Ability to pass full aseptic gowning qualification.
• Knowledge of cGMP/FDA regulations.
• Proficiency in Microsoft Office Suite.

Responsibilities

• Lead daily filling, capping, and lyophilization operations within ISO-classified rooms.
• Ensure 100% compliance with aseptic processing requirements, including gowning and environmental monitoring.
• Design and oversee Media Fills to validate sterility of the process.
• Partner with Engineering on IQ/OQ/PQ of aseptic filling lines, autoclaves, and depyrogenation tunnels.
• Manage the validation and execution of SIP/CIP.
• Lead investigations into environmental monitoring excursions or mechanical failures.
• Develop and refine SOPs for sterile interventions and cleanroom behavior.
• Manage the Gowning and Aseptic Qualification programs for all staff.
• Collaborate with cross-functional teams to meet project goals and timelines.
• Assist in development of Cost of Goods Sold for aseptic processing.
• Support documentation like MBRs and EBRs.
• Mentor operators and identify training needs.
• Ensure compliance with change control, documentation, deviation reporting, cGMP, safety.

Skills

Leadership in aseptic operations

Regulatory compliance knowledge

Team collaboration

Microsoft Office

Education

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

3+ years experience in aseptic filling and sterile operations

Ability to pass full aseptic gowning qualification

Knowledge of cGMP/FDA regulations

Proficiency in Microsoft Office Suite

Job description

Staffmark is hiring an Aseptic Process Manager in San Diego, CA to lead sterile manufacturing operations. You will ensure absolute sterility, oversee daily filling, capping, and lyophilization, and maintain ISO 5 conditions while adhering to global regulatory requirements.

This role partners with Engineering on IQ/OQ/PQ, oversees SIP/CIP, mentors operators, and supports essential documentation (MBRs/EBRs). A Life Sciences degree and 3+ years in aseptic filling are required; salary