Arbetsbeskrivning

Job Title: Sterility Assurance Lead Location: Uppsala Role Summary We are seeking a Sterility Assurance Lead to own and drive the site's sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation. Key Responsibilities * Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in line with EU GMP Annex 1 and global standards. * Oversee 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. Requirements * 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 within the pharmaceutical, biologics, or medical device industry. * Proven experience working in GMP-regulated environments and supporting regulatory inspections and audits. * Hands-on experience with contamination control strategies, environmental monitoring programs, and aseptic manufacturing operations. Skills * Deep technical expertise in aseptic processing, sterilization technologies (moist heat, dry heat, filtration), and microbial contamination control. * Strong knowledge of cleanroom operations, HVAC qualification, isolators/RABS, and environmental monitoring systems. * Solid understanding of EU GMP Annex 1 requirements and familiarity with global regulatory expectations (FDA, EMA, PIC/S). * Experience performing risk assessments using tools such as FMEA, HACCP, or similar methodologies. * Strong analytical mindset with the ability to interpret data trends and drive continuous improvement initiatives. * Excellent documentation skills and a structured approach to problem-solving and investigations. * Strong communication and collaboration skills with the ability to influence cross-functional teams. Your Profile You are a highly motivated sterility assurance professional with a strong quality mindset and a passion for patient safety. You combine deep technical expertise with leadership capabilities and are comfortable acting as a site Subject Matter Expert. You have a proactive and solution-oriented approach, enabling you to identify risks, drive improvements, and support operational excellence. You thrive in a collaborative, cross-functional environment and are able to communicate complex technical topics clearly to both technical and non-technical stakeholders. You are confident leading investigations, mentoring colleagues, and driving initiatives that strengthen contamination control and aseptic manufacturing performance.