At a Glance
- Tasks: Lead sterilization validation and microbiology initiatives to enhance product quality and patient safety.
- Company: Join Convatec, a global leader in medical solutions dedicated to improving lives.
- Benefits: Enjoy remote work flexibility, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with opportunities for mentorship and career advancement.
- Why this job: Make a real impact on healthcare by shaping global quality standards and driving innovation.
- Qualifications: 8+ years in sterilization validation or microbiology; strong problem-solving and communication skills required.
The predicted salary is between 63000 - 77000 £ per year.
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.
- Master's 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.
Senior Sterilization Validation Scientist - Microbiology & Sterilization in Sheffield employer: Convatec
At Convatec, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the heart of Wales. Our commitment to employee growth is evident through comprehensive training programmes and leadership development opportunities, ensuring you can thrive in your role as a Senior Engineering Manager. Join us to be part of a mission-driven team dedicated to making a meaningful impact on lives while enjoying a supportive environment that values your contributions.
