Senior Sterilization Validation Scientist Microbiology & Sterilization

About the role:

Are you passionate about advancing product quality patient safety and innovation in healthcare manufacturing As a Senior Sterilization Validation Scientist you will play a critical role in shaping sterilization and sterility assurance strategies across multiple manufacturing sites and business units. Acting as a trusted technical expert you will lead high-impact initiatives involving sterilization validation microbiology environmental monitoring and contamination control while partnering with global cross-functional teams to bring new products to market and drive continuous improvement.

This is an exciting opportunity to influence global quality standards solve complex technical challenges and contribute directly to products that improve patients lives around the world.

Your key duties and responsibilities:

• Serve as a recognized subject matter expert for sterilization validation sterility assurance and microbiological risk management.
• Support multiple manufacturing facilities contract sterilization providers and cross-functional business units globally.
• Provide scientific leadership on sterilization and microbiological matters supporting new product introductions process improvements and remediation activities.
• Partner with Quality Manufacturing R&D Regulatory Affairs and Supply Chain teams to ensure robust contamination control and sterilization programs.
• Lead sterilization validation and requalification activities across ethylene oxide (EO) radiation steam and other applicable sterilization technologies.
• Develop and execute validation protocols technical reports risk assessments and scientific justifications to support compliance and operational excellence.
• Provide technical oversight for routine sterilization operations and support investigations related to sterilization performance and process deviations.
• Identify opportunities to enhance sterilization processes driving improvements in efficiency compliance and product quality.
• Support environmental monitoring and contamination control programs across manufacturing locations.
• Analyze microbiological and environmental monitoring data identify trends and lead investigations of excursions and atypical events.
• Conduct microbiological and sterilization risk assessments associated with product process material and facility changes.
• Support biological hazard analyses and sterility assurance activities throughout the product lifecycle.
• Collaborate with product development teams to establish sterilization and microbiological requirements for new products and packaging systems.
• Work closely with manufacturing teams to assess process capabilities and implement appropriate contamination control strategies.
• Support change controls CAPAs nonconformances and complaint investigations requiring microbiological or sterilization expertise.
• Participate in supplier qualification activities and provide technical assessments of contract sterilization providers testing laboratories and service partners.
• Act as a technical expert during internal audits customer audits supplier assessments and regulatory inspections.
• Review and approve technical documentation related to sterilization validation and microbiological control systems.
• Mentor junior scientists and provide coaching to help strengthen technical capability across the organization.
• Contribute to the development of global standards procedures and best practices that drive consistency and continuous improvement.
• Ensure compliance with FDA ISO EU MDR GMP and other applicable regulatory requirements.
• Author review and approve technical reports protocols risk assessments procedures and validation documentation.
• Support regulatory submissions and responses involving microbiology and sterilization-related topics.
• Champion safety health and environmental requirements in accordance with established EHS programs.
• Support and strengthen Quality Management Systems aligned with ISO 13485 and FDA cGMP regulations.

Skills & Experience:

• 8 years of experience in sterilization validation microbiology sterility assurance contamination control or related disciplines within regulated industries.
• Significant experience supporting medical device pharmaceutical biologics or healthcare manufacturing environments.

• Demonstrated success leading complex investigations root cause analyses and technical risk assessments.
• Experience supporting multiple manufacturing sites and working within a global business environment.
• Proven experience supporting regulatory inspections audits and validation programs.
• Strong expertise in sterilization validation principles and standards including ISO 11135 ISO 11137 ISO 17665 and ISO 11737.
• Experience designing implementing and maintaining sterilization validation programs in regulated manufacturing settings.
• Working knowledge of environmental monitoring programs contamination control strategies and microbiological testing methodologies.
• Experience interpreting microbiological data conducting trend analyses and driving science-based decision-making.
• Solid understanding of FDA EU MDR GMP ISO 13485 and related regulatory frameworks.
• Strong technical writing analytical thinking and problem-solving capabilities.
• Ability to manage multiple priorities effectively and deliver results in a fast-paced global environment.
• Outstanding communication and stakeholder management skills with the ability to influence cross-functional teams and leadership.
• Experience collaborating with contract sterilization providers and external laboratories is preferred.
• Understanding of medical device biological safety principles and risk management methodologies

Qualifications/Education:

• B.S in Microbiology Biological Sciences Biomedical Engineering or related scientific discipline preferred.
• Masters degree with extensive relevant experience may be considered.

Travel Requirements:

• Position may involve travel up to 25% of the time overseas travel is expected and most trips will include overnight stays.

Working Conditions:

• Remote working in the UK.
• May need to support global discussions in different time zones or impromptu audits.

Ready to join us

At Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.

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Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race religion creed color national origin nationality citizenship ancestry sex age marital status physical or mental disability affectional or sexual orientation gender identity military or veteran status genetic predisposing characteristics or any other basis prohibited by law.

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About Convatec

Pioneering trusted medical solutions to improve the lives we touch:

Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions with leading positions in Advanced Wound Care Ostomy Care Continence Care and Infusion Care. With over 10000 colleagues we provide products and services in around 90 countries united by a promise to be forever caring. Our solutions provide a range of benefits from infection prevention treatment for hard to heal wounds at-risk skin and ulcerated tissue to supporting debilitating conditions improved patient outcomes and reduced care costs. Convatecs revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: .