Sterility Assurance Lead
WHAT WE ARE LOOKING FOR
The Sterility Assurance Lead is responsible for leading the site’s sterility assurance program, ensuring compliance with regulatory requirements, particularly EU Annex 1, and maintaining a robust contamination control strategy (CCS).
YOUR ROLE
Develop, implement, and maintain the site-wide CCS in alignment with Annex 1 and FDA guidance. Lead cross-functional CCS reviews and updates, integrating new risks, CAPAs, and process changes.
Provide technical guidance on contamination risks related to personnel, facility, utilities, equipment, and processes.
Lead sterility risk assessments for aseptic processes, including media fill design and execution. Oversee the environmental and personnel monitoring programs; ensure trending, investigations, and timely responses to excursions.
Evaluate and approve change controls, deviations, and CAPAs related to sterile manufacturing operations. Support batch release decisions with sterility assurance assessments, especially for sterility test investigations and atypical results.
Ensure control of aseptic gowning, behavior, and personnel qualification programs. Oversee aseptic simulation (media fill) programs to verify operational performance and personnel aseptic technique. Evaluate and maintain effective use and integrity of barrier systems such as isolators, PACs, and HEPA systems.
Analyze and interpret project/study/investigation results and findings. Determine next steps under guidance of the manager and in compliance with applicable regulations; carry out technical and administrative duties as assigned.
Review and approve QC test results as well as logbooks for accuracy and completeness and conformance to SOPs.
Provide aseptic behavior and contamination control training to site personnel. Mentor and develop sterility assurance team members and provide subject matter expertise to cross-functional teams.
Act as the SME during internal and external audits and inspections regarding aseptic and sterility assurance systems. Proactively identify and address potential compliance gaps.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS
Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards)
YOUR BACKGROUND
Preferred Skills/Qualifications:
Good interpersonal and verbal/written communication skills; able to use computer for data analysis.
Deep knowledge of aseptic processing, cleanroom standards, isolator/PAC technology, EM programs, and sterility test methods.
Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements.
Self-motivated, energetic, enthusiastic, and team oriented.
Strong understanding of EU Annex 1, FDA guidance, and other global GMP standards.
Proven experience in risk assessment, contamination control strategies, and regulatory compliance.
Other Skills:
Ability to train personnel on various procedures.
MS Excel, PowerPoint, Access, and investigation writing.
Effective communication with both team members and other plant support groups.
Education and Experience:
Bachelor’s Degree preferably in Microbiology, Biology or similar life science.
7+ years of experience in sterile manufacturing (preferably in pharmaceutical manufacturing), with at least 3 years in a sterility assurance or microbiology leadership role.
Reason to Join US
Competitive salary, continued personal development, commitment to improving patient quality of life worldwide, diverse talent pool, and a focus on innovation, cooperation, care, and achievement.
Guerbet
We are an Equal Opportunity Employer committed to diversity, equity, and inclusion. We provide accommodations for applicants with disabilities. For inquiries, please contact careers@guerbet.com or call +19843443717.