Senior Sterilization Validation Scientist – Microbiology, Sterilization

Emploi pas sur LinkedIn

🕒 il y a 4 jours

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟠 Senior

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

Cette entreprise a parrainé des visas de Travailleur Qualifié du Royaume-Uni par le passé.

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Convatec

Site WebLinkedInTous les Emplois

5001 - 10000 employés

Fondée en 1978

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

Healthcare • Consulting • Food & Beverage

Convatec est une entreprise mondiale de produits et technologies médicales, focalisée sur les thérapies pour la gestion des maladies chroniques. Convatec est leader dans les soins avancés des plaies, les soins d'ostomie, les soins de continence et les soins d'infusion. L'entreprise est reconnue pour ses solutions innovantes telles que la technologie Hydrofiber® et la technologie FeelClean™, qui améliorent les résultats pour les patients en optimisant le confort et les soins dans des conditions telles que la gestion des stomies et des plaies. Avec une approche holistique, Convatec offre des produits et des programmes de soutien à travers des plateformes comme me+, visant à permettre aux individus de vivre avec confiance malgré leurs 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

🎯 Exigences

• 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

🏖️ Avantages

• 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