Microbiology and Environmental Compliance Manager

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 around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visithttp://www.convatecgroup.com

At Convatec, we're transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We're aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as a Microbiology and Environmental Compliance Manager, and you'll do the same.

About the role:

Sterilization and Microbiological lead - EO, Irradiation and Steam sterilization for Deeside
Leadership and coordination of the company overall performance in terms of satisfying all the prevailing quality requirements laid down in local documents regarding environmental and sterilization control
Day-to-day overall responsibility for sterilization and environmental control procedures and instructions.
Your key duties and responsibilities:
Manage and support environmental processes, product microbiology, and sterilization issues.
Ensure microbiological evaluation and hygiene monitoring of products and production areas.
Stay updated on international and regional regulatory standards for sterile and un-sterile medical devices.
Maintain knowledge of ETO, Irradiation, and Steam sterilization technologies.
Provide technical direction on environmental and product microbiological controls.
Develop and implement cost-effective policies and procedures for microbiological controls and sterilization processes.
Evaluate physical and microbiological parameters of sterilization processes and release sterile products.
Conduct sampling and testing for particles, air, compressed air, settlement plates, contact plates, finger testing, extruder water, disinfectants, and product bioburden.
Document microbiological and environmental monitoring results.
Maintain microbiological laboratory and equipment.
Assist with clean room cleaning control and perform hygiene education as needed.
Conduct audits focused on hygiene and sterilization processes.
Perform and document microbiological and environmental monitoring tests and trend evaluations.
Review annual Microbiology and Environmental monitoring results.
Support sterilization validation/revalidation activities.
Prepare and update hygiene, microbiology, and sterilization process instructions.
Define and maintain master product for irradiation sterilization.
Review EO, Irradiation, and Steam validation documentation.
Coordinate dose audits and review/approve documentation.
Process NCs related to sterilization and environmental monitoring issues.
Support microbiology, environmental, and sterilization projects.
Implement new or redesigned products impacting sterilization processes.
Integrate standards requirements into local procedures.
Assist with clean room validation and EO/Irradiation sterilization process validations.
Lead multifunctional teams, ensuring qualification and training for all activities.
Ensure compliance with EHS requirements and contribute to company targets.
Skills & Experience:
Minimum 3 years' experience in the Medical Device Industry.
Fluent in English, both verbally and in writing.
Proficiency in MS Office.
Trained in FDA QSR's, ISO 13485, MDSAP medical device regulations
Experience as Auditor - preferred
Experience with sterilization process technology within gas sterilization
Experience with sterilization process technology within radiation sterilization
Thorough knowledge of sterilization standards (EN ISO 11135, EN ISO 11137, EN ISO 17665 EN ISO 556)
Leadership, steadfast expertise and working in cross-functional teams.
Qualifications/Education:
BA degree as Pharmacist, Microbiologist or similar relevant education -university degree
Preferred training requirements: Introduction training for administrative employees.
Quality System documents and procedures relevant to all employees (local and Convatec corporate e.g. Code of Ethics and Business Conduct, Quality Policy, Complaints, relevant GxP documents), including regular re-training when required.
Quality System documents and procedures relevant to job performance.

Working Conditions:
Site-based at Deeside Manufacturing site.
Travel Requirements:
The position may involve travel up to 25% of the time. Such travel may involve overnight departures. Position covers Deeside and Rhymney manufacturing sites.
Our ambitions will bring the very best out in you. You'll be pushed to aim higher and really own your work. You'll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it'll be worth it.

This is stepping up to a challenge.

This is work that'll move you.

#LI-CC1

#LI-Onsite

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Equal opportunities

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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Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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