Senior Validation & Qualification Engineer

About this vacancy

Contribute to the quality of products that make a global impact

Are you an experienced Validation or Qualification Engineer who enjoys working in a complex, technical, and highly regulated environment? Do you want to work for one of the most leading industrial organizations in the Netherlands, where quality, safety, and innovation are at the forefront?

Then we have an exciting position for you.

For our validation and calibration team, we are looking for a Senior Validation & Qualification Engineer who wants to play a key role in ensuring the reliability, compliance, and performance of critical systems, installations, and processes.

Your Impact

As a Senior Validation & Qualification Engineer, you are the subject matter expert in validation, qualification, and calibration. You work closely with process owners, engineering teams, suppliers, and other stakeholders to ensure that processes and equipment meet the highest quality and GMP standards.

You assess complex technical documentation, guide improvement initiatives, and act as a key discussion partner in multidisciplinary projects. Thanks to your expertise, processes remain compliant, efficient, and future-proof.

Welcome to the Team

You will be part of the Validation and Calibration team within Operational Services. This team is responsible for coordinating, executing, and reporting validation, qualification, and calibration activities for multiple locations.

Together with colleagues from Operations, Engineering, Quality, and R&D, you ensure that systems and processes function optimally and comply with all relevant laws and regulations.

What Will You Do?

• Draft, review, and manage validation, qualification, and calibration protocols.
• Prepare reports, annual plans, and technical documentation.
• Review qualification reports, technical files, and as-built documentation.
• Act as Subject Matter Expert (SME) within projects and compliance-related issues.
• Conduct data analyses and registrations in the CMMS system.
• Support audits and inspections.
• Advise stakeholders on qualification, validation, and calibration issues.
• Identify and implement improvements in procedures and working methods.
• Provide technical input for deviations, investigations, and change management processes.
• Ensure knowledge transfer within the organization through coaching, training, and supporting colleagues.

Division of Your Work

• 25% Reviewing reports and technical documentation
• 25% Technical discussions with stakeholders
• 20% Assessing and drafting User Requirement Specifications (URS)
• 20% Improving and safeguarding procedures
• 10% Technical support in deviation and compliance management

What Makes This Role Interesting?

✅ High level of independence and ownership

✅ Work in a high-tech GMP environment

✅ Direct impact on quality, safety, and continuity

✅ Extensive interaction with suppliers, engineering teams, and process owners

✅ Opportunity to propose and implement improvements

✅ A visible role within multidisciplinary projects

What we expect from you

What do you bring?

• A completed HBO degree in a technical field.
• At least 5 to 7 years of experience in the pharmaceutical, biotech, or similar regulated industries.
• Proven experience with validation, qualification, and calibration processes.
• Solid knowledge of GMP guidelines and compliance requirements.
• Experience in reviewing technical documentation and writing reports.
• Strong analytical skills and a structured work approach.
• Good communication skills in both Dutch and English.
• A proactive, customer-oriented, and service-oriented mindset.

You are successful if...

You combine technical depth with a practical mindset. You can distinguish between main points and details, effortlessly interact with various stakeholders, and are not afraid to take responsibility.

You are critical when necessary, pragmatic when possible, and energized by improving processes within a complex technical environment.

What you can expect from us

We offer you:

• A key role within a leading and innovative industrial organization.
• Challenging projects where you have a direct impact on quality, compliance, and business continuity.
• Plenty of room for personal initiative, responsibility, and professional development.
• Collaboration with experienced specialists, engineers, process owners, and quality professionals.
• A working environment that encourages knowledge sharing, continuous improvement, and personal growth.

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