Senior Specialist

vor 5 Monaten

Munich, Deutschland ConvaTec Vollzeit

**About the role**:
As a Senior Specialist - Sterilisation (f/m/d) you will work within prescribed GMP/ISO/GLP Standards and ensure compliance to all applicable national and international regulations. Position supports new and existing products and develops strategies and systems to support sterilization activities for Continence Care business unit. You will Provide sterilization engineering support to both existing manufacturing operations and new product development while working with manufacturing and development teams to evaluate, develop and validate appropriate sterilization processes. Position will have the opportunity to support operations on programs within the cleanrooms and interact with Operations and technical teams on trending, excursions and assessing the impact of environmental or device changes. This role has a direct impact on the quality of existing products, as well as products during design and development.

**Your key duties and responsibilities as a** **Senior Specialist - Sterilisation**:

- Ensure that the company contractual sterilization processes performed at contract sterilization sites are effective and in compliance with all current regulatory requirements.
- Manage, train, and develop site sterilization SMEs.
- Provide training on the QMS documents applicable for the area of sterilization as appropriate.
- Ensure the sterilization control being in compliance with all regulatory requirements, the relevant QMS procedures and/ or instructions maintained, and training provided.
- Provide product disposition in case of NC or discrepancy initiated during routine sterilization of the Continence Care manufactured products.
- Ensure validations and qualifications are prepared in due time and in cooperation with the functions involved in order to ensure their timely completion.

**About you**:

- Experienced about ethylene oxide and radiation principles and industry standards.
- Experienced in sterilization process controls.
- Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards.
- Trained in FDA QSR’s, MDSAP, ISO 13485, EU and Canadian medical device regulations (preferred).
- Lead Auditor (preferred).

**Education / Qualifications**:

- BS in Microbiology preferred. BA/BS in appropriate science, mathematics or Engineering accepted, or 5 years or more experience if no appropriate science degree.
- Communicative level of English language.

**Working Conditions**:
Remote working.

Position may involve travel up to 25% of the time, mostly within Europe but overseas travel is expected.

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-Remote

LI-MD1

**Beware of scams online or from individuals claiming to represent Convatec**

**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**

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