Does helping to make life better for millions of people motivate you?
If the answer is yes, you think just like us. In our daily work, we create unique medical solutions to improve quality of life. We enjoy what we do because it makes a difference in people’s lives – for real. Although we’re a global company, we’re still small enough for you to make your mark. Our leaders are accessible and trust us to make the right decisions. As a Mölnlycke employee, you’ll thrive when you take on the responsibility.
The 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.
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.
- 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
- 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.
This is a full-time permanent position.
We look forward to receiving your application. Please send your CV and cover letter to firstname.lastname@example.org no later than 28 September.
Questions regarding this position: contact Tom Bergqvist, In-house Recruitment Partner at email@example.com or +46 (0)733 – 872722