Sterility Assurance Lead: Aseptic Excellence & Compliance

Q-Med Uppsala; Uppsala kommun; On-site; SEK 1,100,000 - 1,500,000; Full time

Job summary

Q-Med Uppsala is seeking a Sterility Assurance Lead to own and drive the site’s sterility assurance strategy. You will serve as the SME for contamination control, aseptic processing, and sterilization validation, ensuring compliance with global regulatory requirements.

You will lead SAP/CCS programs, oversee environmental monitoring and aseptic operations, and mentor teams to strengthen contamination control and manufacturing performance.

Qualifications

• Bachelor’s or Master’s degree in Microbiology, Biotechnology, Pharmacy, or another relevant life science discipline.
• 8–12 years of experience in sterile manufacturing, microbiology, or sterility assurance.
• Experience in GMP-regulated environments and supporting regulatory inspections/audits.
• Hands-on experience with contamination control strategies and aseptic manufacturing operations.

Responsibilities

• Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in line with EU GMP Annex1 and global standards.
• Oversight of environmental monitoring, cleanroom qualification, and aseptic practices.
• Review sterilization validations and lead media fill programs.
• Drive contamination risk assessments, investigations, and CAPAs.
• Act as SME during audits and inspections.
• Provide training and mentorship in sterility assurance best practices.

Skills

Aseptic processing

Sterilization tech

Contamination control

Cleanroom operations

HVAC qualification

Isolators/RABS

Environmental monitoring

GMP Annex1 familiarity

Regulatory expectations

FMEA

HACCP

Data analysis

Documentation

Education

Bachelor’s or Master’s degree in Microbiology/Biotechnology/Pharmacy

Job description

Q-Med Uppsala is seeking a Sterility Assurance Lead to own and drive the site’s sterility assurance strategy. You will serve as the SME for contamination control, aseptic processing, and sterilization validation, ensuring compliance with global regulatory requirements.

You will lead SAP/CCS programs, oversee environmental monitoring and aseptic operations, and mentor teams to strengthen contamination control and manufacturing performance.