About the Role
We are seeking a Sterility Assurance Lead to own and drive the site's strategy for sterility assurance. The role ensures compliance with global regulatory requirements and serves as an SME for contamination control, aseptic processing, and sterilization validation.
Key Responsibilities:
Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in accordance with EU GMP Annex 1 and global standards.
Oversee environmental monitoring, cleanroom qualification, and aseptic methods.
Review sterilization validations and lead media fill programs.
Drive contamination risk assessments, investigations, and CAPA.
Serve as an SME during audits and inspections.
Provide training and mentorship in sterility assurance best practices.
Your Profile
You are a highly motivated sterility assurance specialist with a strong quality mindset and a genuine commitment to patient safety. You combine deep technical expertise with leadership capabilities and are comfortable serving as the site's Subject Matter Expert. You thrive rather than struggle in a fast-growing environment and contribute with a proactive and solution-oriented approach that allows you to identify risks early, drive improvements, and maintain operational excellence even when priorities shift.
You work well in a collaborative, cross-functional environment and can communicate complex technical topics clearly to both technical and non-technical stakeholders. You are confident in leading investigations, coaching colleagues, and driving initiatives that strengthen contamination control and aseptic manufacturing—and you see this growth phase as an opportunity to grow in your own role.
Requirements:
Bachelor's or Master's degree in microbiology, biotechnology, pharmacy, or another relevant life sciences field.
At least 8 years of experience in sterile manufacturing, microbiology, or sterility assurance within the pharmaceutical, biologics, or medical device industry.
Proven experience in GMP-regulated environments and support during regulatory inspections and audits.
Practical experience with contamination control strategies, environmental monitoring programs, and aseptic manufacturing operations.
Competencies:
Deep technical expertise in aseptic processing, sterilization techniques (moist heat, dry heat, filtration), and microbial contamination control.
Strong knowledge of cleanroom operations, HVAC qualification, isolators/RABS, and environmental monitoring systems.
Good understanding of EU GMP Annex 1 and familiarity with global regulatory requirements (FDA, EMA, PIC/S).
Experience with risk assessments using tools such as FMEA, HACCP, or similar methodologies.
Strong analytical thinking 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.
Application
If you believe this is the right opportunity for you, please submit your application as soon as possible. We evaluate applications on a rolling basis, so do not delay submitting your application. If you have questions about the role or the recruitment process, please feel free to contact Charlotte Duvefelt, [email protected].