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Process Validation Engineer – Medical Devices

Almelo
Full-time
Permanent employee

Major scope of the position

Are you analytically strong, do you enjoy working at the intersection of quality and innovation, and do you want to make an impact in a regulated environment? Then this Validation Engineer role is for you. In this position, you are the driving force behind the validation strategy within our projects. You ensure that (outsourced) processes meet the highest standards of customers, regulatory requirements, and internal quality expectations. You work closely with R&D, suppliers, and internal stakeholders to make processes not only compliant, but also future-proof.

Key Responsibilities

As a Process Validation Engineer, you are responsible for the full validation lifecycle:
  • Define and execute the process validation strategy within projects
  • Collaborate closely with R&D teams and subcontractors
  • Develop validation protocols (IQ, OQ, PQ) using a risk-based approach
  • Monitor project milestones by collecting, analyzing, and translating data into actionable insights
  • Plan and execute sterilization validation activities
  • Coordinate environmental monitoring and climate chamber activities
  • Execute and coordinate non-product software validation

You report to the Manager Quality Improvement and work in a small team where quality, innovation, and collaboration are key.

Your profile

  • A Bachelor’s or Master’s degree in Quality, Mechanical Engineering, Pharmaceutical Sciences, Health Sciences, or a related field
  • At least 2 years of experience in a relevant quality role
  • A strong analytical and structured working style
  • A proactive mindset and solid communication skills
  • You are both pragmatic and flexible, and able to adapt to change

What we offer

What makes this role interesting?
  • You will have a high level of responsibility and ownership within projects
  • You will work in an environment where quality and innovation go hand in hand
  • You will have a direct impact on processes that are essential for safe and reliable products
  • Collaboration with various teams and external partners ensures a dynamic and varied role

 What we offer:
  • Competitive salary
  • Bonus equivalent to one month’s salary
  • 28 vacation days
  • Hybrid working options (possibility to work partly from home)
  • Company bike lease plan

Do you want to refer someone for this job?

​https://tsc-life.app.personio.com/recruiting/applications/refer

About us

We are a global leader in the medical industry, commited to support sustainable and accessible patient care.

Our mission is to drive innovation by creating evidence-based solutions that empower healthcare professionals to improve patient outcomes. With a bold vision of touching the lives of 25 million patients annually, we aim to disrupt the healthcare market through agility, integrity, and reliability. Our commitment to continuous improvement ensures that we not only meet but exceed the expectations of our partners, patients, and stakeholders, fostering a healthier, more sustainable future for all.


Our core values

Our Mission: We drive innovation to revolutionize sustainable, accessible patient care. We develop cutting-edge, evidence-based solutions that empower healthcare professionals to improve patient outcomes, ensuring that high-quality care is both accessible and sustainable.


Our Vision: Independent, disruptive innovator with 25 million patients per year benefiting from our products. We are a magnet for talent. We push medical technology forward, improving patient care with transformative solutions. Our commitment to excellence and bold vision position us as a leading disruptor in healthcare.