Senior Sterilization Validation Scientist – Microbiology, Sterilization

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Act as a recognized authority in sterilization validation, sterility assurance, and microbiological risk management.

• Provide support to various manufacturing facilities, contract sterilization providers, and cross-functional business units on a global scale.

• Offer scientific leadership for the introduction of new products, process enhancements, and remediation efforts.

• Collaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and Supply Chain teams on contamination control and sterilization initiatives.

• Direct sterilization validation and requalification efforts utilizing EO, radiation, steam, and other technologies.

• Create and implement validation protocols, technical reports, risk assessments, and scientific justifications.

• Oversee routine sterilization operations and investigate any process deviations.

• Improve sterilization processes to enhance efficiency, compliance, and product quality.

• Assist with environmental monitoring and contamination control programs.

• Analyze microbiological and environmental monitoring data, identify trends, and lead investigations into excursions.

• Conduct microbiological and sterilization risk assessments for changes in product, process, material, and facility.

• Support biological hazard evaluations and sterility assurance throughout the product lifecycle.

• Work alongside product development teams to define sterilization and microbiological requirements.

• Evaluate process capabilities and implement contamination control strategies in collaboration with manufacturing teams.

• Assist with change controls, CAPAs, nonconformance issues, and complaint investigations.

• Engage in supplier qualifications and assess contract sterilization providers, testing laboratories, and service partners.

• Serve as a technical expert during audits, assessments, and regulatory inspections.

• Review and authorize technical documentation related to sterilization validation and microbiological control systems.

• Mentor junior scientists and enhance technical capabilities across the organization.

• Contribute to the development of global standards, procedures, and best practices.

• Ensure adherence to FDA, ISO, EU MDR, GMP, and other relevant requirements.

• Assist with regulatory submissions and responses concerning microbiology and sterilization.

• Promote safety, health, and environmental compliance.

• Support Quality Management Systems in alignment with ISO 13485 and FDA cGMP regulations.

⛳️ Requirements

• A minimum of 8 years of experience in sterilization validation, microbiology, sterility assurance, contamination control, or related fields within regulated industries.

• Substantial experience in medical device, pharmaceutical, biologics, or healthcare manufacturing settings.

• Demonstrated success in leading complex investigations, root cause analyses, and technical risk assessments.

• Experience in supporting multiple manufacturing sites and working within a global business framework.

• Familiarity with regulatory inspections, audits, and validation programs.

• Strong knowledge of ISO 11135, ISO 11137, ISO 17665, and ISO 11737 standards.

• Proven experience in designing, implementing, and maintaining sterilization validation programs.

• Proficient understanding of environmental monitoring, contamination control strategies, and microbiological testing methodologies.

• Experience in interpreting microbiological data and performing trend analyses.

• Insight into FDA, EU MDR, GMP, ISO 13485, and other related regulatory frameworks.

• Excellent technical writing, analytical thinking, and problem-solving skills.

• Ability to manage multiple priorities and achieve results in a dynamic global environment.

• Exceptional communication and stakeholder management abilities.

• Experience working with contract sterilization providers and external laboratories is preferred.

• Understanding of medical device biological safety principles and risk management methodologies.

• A Bachelor’s degree in Microbiology, Biological Sciences, Biomedical Engineering, or a related scientific field is preferred.

• A Master's degree with extensive relevant experience may also be considered.

• Position may require up to 25% travel; international travel is anticipated, and most trips involve overnight stays.

• Capability to support global discussions across various time zones and participate in impromptu audits.

🏝️ Benefits

• Flexible remote working options within the UK.

• Opportunities for travel, including international destinations.

• Chance to contribute to products that enhance patients' lives.

• Opportunities for coaching and mentoring.

• Commitment to equal employment opportunities.