Sterility Assurance Lead

Overview

CareerWise Recruitment is seeking a dedicated Sterility Assurance Lead for a position based in Galway, Ireland. This role is central to maintaining the sterility of injectable products by implementing robust contamination control and assurance protocols that extend well beyond microbiological testing. The lead will ensure compliance with global regulatory standards, particularly in aseptic manufacturing, contamination risk management, and will promote a culture committed to quality excellence.

Primary Responsibilities

• Develop and execute comprehensive sterility assurance frameworks aligned with Annex I and global GMP standards.
• Perform risk assessments on aseptic processes, environmental monitoring systems, and container closure systems to minimize contamination risks.
• Enhance aseptic methodologies, including gowning procedures and sterile manufacturing controls.
• Manage and refine environmental monitoring programs to support contamination risk mitigation.
• Investigate environmental monitoring anomalies, identify root causes, and implement corrective measures.
• Supervise contamination control practices, including cleaning and disinfection protocols.
• Lead validation and revalidation of sterility-related tests and aseptic process simulations including media fills.
• Provide expertise during internal and external regulatory audits, addressing sterility assurance queries and facilitating audit responses.
• Lead and mentor a multidisciplinary team, offering training on aseptic and contamination control principles.
• Collaborate with Quality, Manufacturing, and Engineering departments to ensure sterility assurance alignment.
• Advise manufacturing on sterility deviations and corrective action plans; lead microbiological investigations to determine causes and solutions.
• Oversee documentation including SOPs, validation protocols, contamination control plans, and trend analysis reports.
• Coordinate site-wide sterility assurance initiatives and meetings to communicate trends and improvement proposals to senior leadership.
• Support qualification processes for isolators and laboratory equipment integral to sterility assurance.

Candidate Requirements

• Bachelor's degree in Microbiology, Biotechnology, or related fields.
• 2 to 4 years of experience in sterility assurance or aseptic manufacturing.
• In-depth knowledge of Annex I, US and EMA GMP regulations with audit experience.
• Expertise in contamination control strategies, including cleaning and disinfection validations.
• Practical experience in aseptic processing validations, environmental monitoring, and isolator technology.
• Proven leadership capabilities in team development and investigation management.
• Strong risk assessment and problem-solving skills in sterility assurance.
• Competence with contamination control software tools such as MODA, Excel, and project management platforms.
• Excellent communication skills and ability to foster cross-functional collaboration.
• Focused on developing a comprehensive sterility assurance culture ensuring patient safety through consistent regulatory compliance and contamination control.

Additional Information

Candidates must be eligible to work in the European Union and willing to relocate to Galway, Ireland with proper visa arrangements.