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Työnimike: Global Sterilization Engineer

Työnkuvaus:
We are now looking for the Global Sterilization Engineer, under the responsibility of the Global Sterilization Manager, will be responsible for activities necessary to support the worldwide manufacture and sterilization of sterile products.

This is a full-time permanent position and can be base in any European location.

As a Global Sterilization Engineer you support the organization in order to ensure compliance with external and internal sterilization and microbiology requirements. You will prepare and execute activities among various divisions, manufacturing and sterilization facilities and laboratories.

Your role
 
Monitor and follow up supplier quality and manufacturing capabilities proactively, in line with standards and regulations applicable
Support the implementation and maintain adequate microbiological /sterilization processes to ensure product safety and compliance in our internal sites
Contribute and monitor required validations based on external standards
Perform internal and supplier audits (microbiology /sterilization/ laboratories)
Contribute to projects and be the sterilization representative
Support R&D needs within the sterilization area
Participates in CAPA, FMEA and other failure investigation activities related to sterilization and GMP
Actively contribute to the development of internal sterilization processes

Qualifications

At least five years of working experience within the quality area, preferably from the sterilization, medical device, pharmaceutical, or food industry and with a clearly identified experience with microbiology or sterilization processes.
Sterilization and Microbiology knowledge and related standards.
Knowledge of ISO13485, MDD and GMP, FDA QSR 820 would be considered as an advantage.
Experience in process validation, audits, manufacturing.
Masters' degree preferably in microbiology, pharmacy, quality or chemistry.
Good team-working and communication skills.
English written and spoken.

To be successful you are action oriented with great analytical skills, planning skills and used to perform with high quality within deadlines. It is essential having a good ability to structure and prioritize.

Since our operations covers a large geographical area travelling will be required.

Closing date for applications is 30th of April, but we have an ongoing review of candidates.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2141

positionTypeCode: directhire

Työnantajan nimi: Mölnlycke Health Care Oy

source: TIVA