Sterility Assurance Lead M/F (30472)

Laboratoire Guerbet • Raleigh, IL

2d

About The Position

Under the direction of the Site Quality Manager, the Sterility Assurance Manager 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). This role oversees aseptic processing standards, Pre-Autoclave Bioburden control, cleanroom behavior and monitoring, and drives sterility assurance oversight for sterile manufacturing operations. The position supports a culture of quality, risk management, and continuous improvement in sterile product manufacturing. The candidate must have the ability to work with a sense of urgency, assist with maintenance and analysis of Microbiological data, and work with other plant personnel to resolve problems related to actual or potential product quality problems. The candidate will work with, and guide the efforts of Microbiology lab personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with approved SOPs and regulatory documents.

Requirements

• 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.
• 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.
• 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.

Nice To Haves

• Preferred Skills/ Qualifications:

Responsibilities

• 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.
• Serve as the site expert on EU GMP Annex 1 requirements. Ensure sterility assurance practices align with current Annex 1 revisions, especially regarding risk-based aseptic practices, environmental monitoring, and CCS. Facilitate readiness and response to regulatory inspections focusing on Annex 1 compliance.
• 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.
• Analyzes and interpret project/study/investigation results and findings. Determines next steps under guidance of the manager and in compliance with applicable regulations; carries out technical and administrative duties as assigned. Responsible for review and approval 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
• 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.
• Other duties as assigned with or without accommodation.
• Proactively manage and maintain regulatory compliance (US/EU/WHO/Brazilian/Korean standards)

Benefits

• Much more than a Competitive salary,
• We offer continued personal development.
• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level