Oversigt
Play a crucial role at BioPorto in bringing a lifesaving product to the US market!
If you are an experienced Validation Specialist with knowledge of validation in a medical device environment, this could be the job for you!
As a Validation Specialist you have the key role in defining and continuously updating the validation strategy together with QA. In this position at BioPorto, you will be responsible for planning and executing qualification and validation of equipment, software, and processes, monitoring validated processes, and presenting validations at audits.
At BioPorto you will have an exciting and varied job with excellent opportunities for personal and professional development. Your engagement and the influence you create in processes and workflows will help define the framework as well as shaping and expanding the standard of collaboration in the organization.
Key responsibilities in this position:
- Defining the validation strategy for BioPorto and continuously keeping it updated
- Ensuring that the Validation Master Plans (VMPs) are up to date
- Planning and executing qualification and validation of equipment, software, and processes in close collaboration with production and R&D
- Monitoring validated processes
- Participate in external audits and present validation and QA
- QA release of products for packaging and sale
- Perform internal and external audits as well as supplier management
- Assist the company in maintaining and developing a proper quality spirit through training of colleagues
- Participation in the company's transition to new European rules under IVDR
- Be part of the implementation of Master Control as a new it tool for the validation area
Who are we looking for?
The ideal candidate should have a B.Sc. or a higher degree in engineering, biotechnology or a similar field along with knowledge of qualification and validation, GMP, Quality Systems Standards ISO13485, FDA CFR21 part 820, and IVD/Medical legislation. Fluency in English, both written and spoken, is a must.
In terms of personality, the organization needs a team player who is collaborative, proactive and flexible in thinking. You must be willing to go the extra mile to help your colleagues, take the initiative to solve problems within your area of responsibility and be able to adapt to changing priorities.
Risk-taking and motivation to drive forward and execute tasks are necessities in this role.
Your qualifications
- Education as B.SC. or higher within engineering, biotechnology, or similar relevant experience
- Knowledge of qualification and validation, both in theory and practical experience
- Knowledge of GMP
- Knowledge of Quality Systems Standards ISO13485, FDA CFR21 part 820 and IVD/Medical legislation
- Fluency in reading, speaking, and writing English
- Team play and willingness to go the extra mile to help a colleague
- Knowledge from pharma, biotech, or the medical device industry is an advantage
- To be considered for this position, in addition to the required qualifications, you must hold a valid Danish residence and work permit.
Your new international team
This company within Life Science has approximately 30 dedicated employees worldwide, most of them work at the beautiful HQ in Hellerup. The size of the organization at BioPorto is important since you will quickly get to know the entire office. Likewise, your new American colleagues will drop by the office on a regular basis, adding a global twist to the international team of colleagues in production. For connectivity and day-to-day contact, when not in the same location, the use of Teams meetings is regular, and you will be expected to be proactive in using the media when needed.
You will work in a small and informal team, in close collaboration with other team members, including international colleagues, and you will influence your line of work.
BioPorto is based in Tuborg Havn in ‘the Cube’ where you will enjoy the light office space, the great canteen, and hopefully participate in our shared ‘post lunch walk’ around the harbor area. The organization can be characterized as energetic, passionate, and committed to providing a supportive work environment.
An attractive salary package adapted to your qualifications is part of this unique opportunity.
Apply
If you are interested and feel you are the right person for the job, do not hesitate to send a short application along with your resume. Temp-Team A/S is responsible for this recruitment and all inquiries must be directed to Temp-Team.
Temp-Team
Temp-Team A/S is a national recruitment and temp agency with eight local branches in Denmark. We have more than 40 years of experience within staffing and cover a wide range of industries. We provide an excellent service of high quality and a close personal contact to our candidates and clients.Temp-Team is a part of JuhlerGroup - an international group of recruitment agencies.
