Environmental Manager
Environmental Manager
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Job Description
At Convatec were transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. Were aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as an Environmental Manager and youll 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
- Daytoday 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 unsterile medical devices.
- Maintain knowledge of ETO Irradiation and Steam sterilization technologies.
- Provide technical direction on environmental and product microbiological controls.
- Develop and implement costeffective 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 QSRs 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 crossfunctional 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 retraining when required.
- Quality System documents and procedures relevant to job performance.
Working Conditions:
- Sitebased 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. Youll be pushed to aim higher and really own your work. Youll 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 itll be worth it.
This is stepping up to a challenge.
This is work thatll move you.
#LICC1
#LIOnsite
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media text message email or phone call about recruitment at Convatec do not disclose any personal information or pay any fees whatsoever. If youre unsure please contact us at .
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.
Notice to Agency and Search Firm Representatives
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.
Already a Convatec employee
If you are an active employee at Convatec please do not apply here. Go to the Career Worklet on your Workday home page and View Convatec Internal Career Site Find Jobs. Thank you!
Required Experience:
Manager
Employment Type
Full-Time
