Validation Engineer
Location: Tampere, Finland
Employment type: Permanent, full time
Application deadline: 9.11.2025
Are you motivated by the opportunity to ensure that life-enhancing medical devices are produced with the highest standards of safety and quality? We are looking for a Validation Engineer to join our validation team and take responsibility for process validation activities within our medical device manufacturing operations.
In this role, you will ensure that all production processes are validated or verified, compliant with regulatory requirements, and capable of consistently delivering high-quality products that improve patients’ lives
Key responsibilities:
- Plan, execute, and document process validation and process verification activities in compliance with internal procedures and applicable regulatory requirements (ISO 13485, FDA).
- Support the implementation of new production equipment by planning and performing equipment qualifications.
- Develop and maintain validation master plans, protocols, and reports.
- Support process development and continuous improvement initiatives by applying validation and statistical methodologies.
- Conduct data analysis and utilize statistical tools to evaluate process capability and performance.
- Collaborate with R&D, Quality, Production, and Laboratory teams to ensure effective process transfer and robust production performance.
- Contribute your expertise to risk management in manufacturing processes.
Qualifications and skills:
- Sc. or B.Sc. degree in Engineering or a related technical discipline.
- Experience in process validation and/or process development, preferably in the medical device or other regulated industry. Understanding of biopolymer melt processing processes is an advantage.
- Strong understanding of process verification and validation principles, as well as regulatory requirements for medical devices.
- Knowledge of statistical techniques and tools for data analysis and validation (e.g., process capability, DOE). Six Sigma certification is considered an advantage.
- Knowledge of process risk management
- Familiarity with equipment calibration and maintenance practices.
- Analytical, structured, and detail-oriented approach to work.
- Proven ability to work independently and collaboratively in a multidisciplinary environment.
- Excellent documentation, planning, and reporting skills.
- Fluent in Finnish and English, both spoken and written.
- Proficiency in Microsoft Office, especially Excel; experience with Minitab and M-Files is an advantage.
Why join us?
At Arctic Biomaterials, we are dedicated to developing and producing medical devices that make a real difference in patients’ lives. As a Validation Engineer, you will play a key role in ensuring that our manufacturing processes meet the highest quality and regulatory standards. We offer an innovative, collaborative, and quality-driven work environment where you can grow your expertise and contribute to advancing healthcare. Our enthusiastic team is always ready to help and encourage colleagues to use and grow their skills daily.
You will report to Quality Director.
About us:
Arctic Biomaterials Oy (ABM) offers a unique opportunity to work in the innovative field of bioabsorbable materials and technologies. ABM is a company producing bio-based and/or biodegradable compound and composite solutions. ABM’s proprietary technology enables the production of biodegradable fiber-reinforced materials that meet the requirements of demanding medical applications by providing bioresorbable composite solutions with enhanced strength.
Join us in our journey to make sure we give future generations the possibility to enjoy an innovative, green and healthy planet.
Send your application with CV and salary request by 9.11.2025 to HR Manager Pauliina Oja, pauliina.oja@abmcomposite.com.
