Position Overview
We are looking for a dedicated Sterility Assurance Lead to drive contamination control and aseptic assurance strategies for sterile injectable manufacturing. This role is central to safeguarding product sterility, supporting regulatory compliance, and promoting continuous improvement in cleanroom practices and microbiological controls. The successful candidate will collaborate across departments to embed a culture of sterility assurance and operational excellence.
Key Responsibilities
As a Sterility Assurance Lead, your contribution will have a significant impact across multiple quality and manufacturing areas. Core responsibilities include:
- Design and implement sterility assurance frameworks, including contamination control strategies aligned with global GMP standards and Annex I requirements.
- Conduct and lead risk assessments for aseptic processes, cleanroom environments, environmental monitoring, and container closure systems.
- Champion continuous improvements in gowning, aseptic techniques, and operational behaviors within sterile production areas.
- Oversee and continuously optimize the environmental monitoring program to support aseptic manufacturing operations.
- Investigate out-of-specification (OOS) environmental results, perform root cause analyses, and implement corrective and preventive actions (CAPAs).
- Manage contamination control programs including cleaning, disinfection, and associated validation activities.
- Coordinate the planning, execution, and review of aseptic process simulations (media fills) to ensure compliance and process robustness.
- Lead sterility-related validation activities for aseptic manufacturing and microbiological methods.
- Represent sterility assurance during internal and external audits, managing observations and ensuring timely, effective responses.
- Lead and mentor a cross-functional team focused on achieving sterility assurance goals.
- Provide aseptic technique and contamination control training to internal stakeholders.
- Act as a technical advisor to manufacturing, supporting investigations and CAPA development for sterility-related deviations.
- Lead microbiology investigations, ensuring thorough root cause identification and sustainable corrective actions.
- Approve and maintain essential documentation, including SOPs, contamination control plans, protocols, and reports.
- Establish and lead a site-wide sterility assurance governance program, including regular performance reviews with site leadership.
- Monitor and report on sterility assurance metrics, identifying trends and opportunities for improvement.
- Support qualification activities for isolators and critical laboratory or manufacturing equipment related to sterility assurance.
Qualifications & Experience
The ideal candidate will bring a balanced mix of technical expertise and leadership experience, including:
- Education: Bachelor's degree in Microbiology, Biotechnology, or a related field.
- Experience: 2-4 years in sterility assurance, aseptic manufacturing, or related areas (equivalent combinations of education and experience considered).
- Experience with contamination control in a GMP environment is a must.
- Regulatory Knowledge: Strong understanding of global GMPs, including Annex I, US FDA, and EMA requirements, with experience in inspections/audits.
- Technical Skills: In-depth knowledge of contamination control, isolator systems, environmental monitoring, and aseptic process validation.
- Leadership: Proven ability to mentor teams, lead investigations, and manage cross-functional projects.
- Problem-Solving: Skilled in root cause analysis, risk assessment, and CAPA implementation related to sterility risks.
- Digital Proficiency: Experience using monitoring platforms (e.g., MODA), MS Excel, and project management tools.
- Communication: Strong written and verbal communication skills, with the ability to work collaboratively across Quality, Manufacturing, and Engineering teams.