Senior Sterilization Validation Scientist – Microbiology, Sterilization

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🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

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Convatec

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1978

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Convatec is a global medical products and technologies company focused on therapies for the management of chronic conditions. Convatec leads in advanced wound care, ostomy care, continence care, and infusion care. The company is known for its innovative solutions like Hydrofiber® Technology and FeelClean Technology™, which enhance patient outcomes by improving comfort and care in conditions such as stoma and wound management. With a holistic approach, Convatec offers products and support programs through platforms like me+, aiming to empower individuals to live confidently with their conditions.

📋 Description

• 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 for new product introductions, process improvements, and remediation activities • Partner with Quality, Manufacturing, R&D, Regulatory Affairs, and Supply Chain teams on contamination control and sterilization programs • Lead sterilization validation and requalification activities across EO, radiation, steam, and other technologies • Develop and execute validation protocols, technical reports, risk assessments, and scientific justifications • Provide technical oversight for routine sterilization operations and investigations into process deviations • Enhance sterilization processes to improve efficiency, compliance, and product quality • Support environmental monitoring and contamination control programs • Analyze microbiological and environmental monitoring data, identify trends, and lead excursion investigations • Conduct microbiological and sterilization risk assessments for product, process, material, and facility changes • Support biological hazard analyses and sterility assurance throughout the product lifecycle • Collaborate with product development teams to establish sterilization and microbiological requirements • Assess process capabilities and implement contamination control strategies with manufacturing teams • Support change controls, CAPAs, nonconformances, and complaint investigations • Participate in supplier qualification and assess contract sterilization providers, testing laboratories, and service partners • Act as technical expert during audits, assessments, and regulatory inspections • Review and approve technical documentation related to sterilization validation and microbiological control systems • Mentor junior scientists and coach technical capability across the organization • Contribute to global standards, procedures, and best practices • Ensure compliance with FDA, ISO, EU MDR, GMP, and other applicable requirements • Support regulatory submissions and responses involving microbiology and sterilization • Champion safety, health, and environmental requirements • Support Quality Management Systems aligned with ISO 13485 and FDA cGMP regulations

🎯 Requirements

• 8+ years of experience in sterilization validation, microbiology, sterility assurance, contamination control, or related disciplines within regulated industries • Significant experience in medical device, pharmaceutical, biologics, or healthcare manufacturing environments • Proven success leading complex investigations, root cause analyses, and technical risk assessments • Experience supporting multiple manufacturing sites and working in a global business environment • Experience supporting regulatory inspections, audits, and validation programs • Strong expertise in ISO 11135, ISO 11137, ISO 17665, and ISO 11737 • Experience designing, implementing, and maintaining sterilization validation programs • Working knowledge of environmental monitoring, contamination control strategies, and microbiological testing methodologies • Experience interpreting microbiological data and conducting trend analyses • 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 and deliver results in a fast-paced global environment • Outstanding communication and stakeholder management skills • Experience collaborating with contract sterilization providers and external laboratories preferred • Understanding of medical device biological safety principles and risk management methodologies • B.S. in Microbiology, Biological Sciences, Biomedical Engineering, or related scientific discipline preferred • Master's degree with extensive relevant experience may be considered • Position may involve travel up to 25% of the time; overseas travel is expected and most trips include overnight stays • Ability to support global discussions across different time zones and impromptu audits

🏖️ Benefits

• Remote working in the UK • Travel opportunities, including overseas travel • Opportunity to contribute to products that improve patients' lives • Coaching and mentoring opportunities • Equal employment opportunities