Sterility Assurance Manager - 19055

Assignment Description

We are looking for an experienced Sterility Assurance Lead

What You Will Work On

• Lead the Sterility Assurance Program (SAP)
• Develop and maintain the Contamination Control Strategy (CCS)
• Ensure compliance with EU GMP Annex 1
• Oversee environmental monitoring programs
• Support cleanroom qualification and aseptic practices
• Review sterilization validation activities
• Lead media fill programs
• Drive contamination risk assessments, investigations and CAPAs
• Act as SME during audits and regulatory inspections
• Provide training and mentorship in sterility assurance
• Analyze microbiological and environmental monitoring trends
• Support HVAC, isolator and RABS qualification activities
• Drive continuous improvement in contamination control
• Collaborate with QA, manufacturing, engineering and other cross-functional teams

What You Bring

• Bachelor’s or Master’s degree in Microbiology, Biotechnology, Pharmacy or relevant Life Sciences
• 8–12 years of experience in sterile manufacturing, microbiology or sterility assurance
• Experience within pharmaceutical, biologics or medical device environments
• Proven experience in GMP-regulated environments
• Experience supporting regulatory audits and inspections
• Hands-on experience with Contamination Control Strategies
• Strong experience with environmental monitoring and aseptic manufacturing
• Deep knowledge of aseptic processing and sterilization technologies
• Experience with moist heat, dry heat and filtration
• Strong understanding of cleanroom operations
• Experience with HVAC qualification, isolators/RABS and environmental monitoring systems
• Strong knowledge of EU GMP Annex 1
• Familiarity with FDA, EMA and PIC/S expectations
• Experience with risk assessment methods such as FMEA or HACCP
• Strong analytical, documentation and investigation skills
• Excellent communication and stakeholder management skills

Interested? Please share your updated CV at cv@veritaz.se to proceed further.