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Sterility Assurance Lead

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BioMarin Pharmaceutical

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Location:
Ireland , Cork

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

This is a critical leadership role responsible for ensuring that all marketed and investigational drug products manufactured at our site meet the highest sterility and contamination control standards. The successful candidate will act as a key influencer across the site and global operations, shaping contamination control strategies and driving compliance with regulatory expectations. This is an exciting opportunity for a proactive leader to define and implement sterility assurance programs, collaborate cross-functionally, and represent the site as a subject matter expert during audits and inspections.

Job Responsibility:

  • Strategic Leadership: Own and continuously evolve the site’s Contamination Control Strategy, ensuring alignment with global standards and regulatory requirements
  • Regulatory Compliance & Influence: Implement regulatory expectations, maintain compliance with EU GMP Annex 1, 21 CFR, USP, EP, JP, and ICH guidelines, and stay current with emerging global regulations, audit trends and best practices
  • Training & Culture: Design and deliver robust training programs on aseptic processing, behaviors, and contamination control principles to embed a culture of sterility assurance across the site
  • Environmental Monitoring & Utilities: Establish and maintain environmental monitoring and clean utilities programs, ensuring proactive contamination control
  • Technical Expertise: Provide expert input on gowning, cleaning, sanitization & sterilization strategies, microbiological method transfers, and contamination investigations
  • Investigations: Lead and guide the investigation of contamination-related deviations, non-conformances, and sterility failures. Perform root cause analysis, define corrective and preventive actions (CAPAs), and ensure timely closure of quality events
  • Data Analysis & Risk Mitigation: Review microbiological data trends, identify risks, and implement effective mitigation strategies
  • Global Collaboration: Partner with global Technology and Quality functions to ensure site alignment with industry best practices and BioMarin network standards
  • Continuous Improvement: Drive initiatives to enhance microbiological quality, operational efficiency, and inspection readiness
  • Facility Expansion Support: Lead microbiology aspects of facility expansions, including cleanroom qualification and sterilization systems

Requirements:

  • Bachelor’s degree in Microbiology, Biology, Pharmaceutical Sciences, or related discipline (Master’s or PhD preferred)
  • 10–15+ years of progressive experience in microbiology within GMP-regulated pharmaceutical or biotechnology environments
  • Minimum 5 years in leadership roles, with proven ability to influence cross-functional teams and senior stakeholders
  • Significant hands-on experience supporting aseptic sterile fill-finish operations, preferably with isolator qualification and maintenance
  • Strong knowledge of EU GMP Annex 1 and global sterility assurance standards
  • Demonstrated success in leading contamination investigations and regulatory interactions
  • Strategic thinker with strong problem-solving and decision-making abilities
  • Excellent communication and influencing skills across all organizational levels
  • Ability to interpret complex microbiological data and translate into actionable strategies

Additional Information:

Job Posted:
January 06, 2026

Work Type:
On-site work
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