Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as a Specialist II- Sterilization , and you’ll do the same.
Key Responsibilities
Hence forward, "sterilization" implies "Ethylene Oxide (EO/EtO) Sterilization" only.
Unless stated specifically the functional area is for the Denmark and Mexico locations of Infusion Care business area only.
Supported by the IC BU Sterilization SME, this role will focus on:
The MDR compliance effort related to Sterilization.
Day-to-day support for sterilization procedures and instructions.
Participation in Product Development in terms of determination of sterilizability of the new/altered product design to ensure optimal sterilization.
Participation in Process Development relating to the sterilization process.
Preparation of validation protocols for sterilization processes within the cycles and products related to Infusion Device area. Review of protocols and reports from other business units on request.
Participation in Validation activities on a level to make it possible to review/approve the documents related to the activities such as validation reports.
Preparation of Procedures and Work Instructions within the sterilization area.
Perform or participate in internal and external sterilization/production site audits.
Provide support in connection with product registrations and/or inquiries from authorities and customers, and customer audits.
Support training of QA/QC staff related to release of sterilized products.
Participate in projects to support sterilization, sterility assurance, contamination controls and sterilant residue related projects.
To provide product disposition in case of NC or discrepancy initiated during routine sterilization of the Infusion care manufactured products.
To ensure validations and qualifications are prepared in due time and in cooperation with the functions involved in order to ensure their timely completion.
To provide training on the QMS documents applicable for the area of sterilization as appropriate.
To ensure the sterilization control being in compliance with all regulatory requirements, the relevant QMS procedures and/ or instructions maintained, and training provided.
Skills & Experience
Excellent communication skills
Proficiency in MS Office (required)
Qualifications/Education
BS in Microbiology preferred. BA/BS in appropriate science, mathematics or Engineering accepted, or min 3 years or more experience if no appropriate science degree.
Demonstrates knowledge of ethylene oxide and radiation principles and industry standards and experience in sterilization process controls is a must.
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.
Fluent in English, both verbally and in writing (required).
Trained in FDA QSR’s, MDSAP, ISO 13485, EU and Canadian medical device regulations (required).
Lead Auditor (preferred).
Travel Requirements
Position may involve travel up to 25% of the time, mostly within Europe but overseas travel is expected. Most trips will include overnight travel.
Languages
Speaking: Yes English, Danish*
Writing/Reading: Yes English, Danish*
Working Conditions
Remote working
Our progress will give you countless opportunities to move forward too. Seek out new challenges, and you’ll find them. Stretch your thinking, and you’ll find new ways to make an impact. And if you embrace the opportunity to drive your own growth, you could go further, and achieve more, than ever before.
This is a big step forward.
This is work that’ll move you.
#LI-SF1
#LI-Remote
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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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