Senior Validation/Qualification Engineer

Job Description

Do you want to apply your technical expertise at one of the largest industrial players in the Netherlands? Do you enjoy working in a high-tech environment where you make an impact with products that truly matter? Then we are looking for you!

For our department, we are looking for a Senior Validation/Qualification Engineer.

Welcome to our team

You will be part of the technical service validation and calibration team, which is responsible for coordinating, executing, and reporting on validations, qualifications, and calibrations for our various locations. We work closely with various departments, such as integrated process teams, centers of expertise, and the Research & Development department.

As a Senior Validation/Qualification Engineer, you are the expert in the field of validation, qualification, and calibration. You develop and manage validation and qualification protocols and actively contribute to improving our processes. You analyze data, identify opportunities for improvement, and substantiate these with clear improvement proposals. In doing so, you not only increase productivity but also safety and quality within our organization.

About the role

In the first year, you are expected to show affinity with the industry and relevant areas of knowledge. This forms the basis for effective collaboration within the team. You contribute to preventing backlogs and ensuring quality.

The goal is to be fully onboarded after one year and to be able to contribute independently, noticeably reducing the team's workload. Success is measured by independence and impact on the team.

Distribution of tasks:

• Review of reports (25%)

• User Requirements Specification input/evaluations (20%)

• Technical consultation with stakeholders (25%)

• Improving and safeguarding procedures (20%)

• Technical input for deviation management (10%)

Stakeholders: suppliers, process owners, direct colleagues, and engineering teams.

What will you do?

• Drafting, checking, and managing validation, qualification, and calibration protocols, including reports and annual plans.

• Executing data analyses and registrations in the CMMS system, with a focus on continuous process improvement.

• Assessing technical documentation such as qualification and 'as built' reports, and providing support during audits.

• Acting as a Subject Matter Expert (SME) in the field of qualification and calibration within projects and for compliance issues.

• Safeguarding knowledge and supporting departments with technical expertise and training.

• Ensuring compliance with safety, health, and environmental policies and relevant laws and regulations.

Your profile

• Bachelor's degree (HBO) in a technical field and 5–7 years of experience in the pharmaceutical industry.

• Demonstrable knowledge of GMP and experience with validation and calibration processes.

• Strong in analyzing technical documents and writing clear reports.

• Communicatively skilled in Dutch and English.

• Analytically strong, with a customer-oriented and service-oriented attitude.

• Flexible, proactive, and able to work both independently and in a team.

What we offer

Working at our organization means working together on health in an international work environment with dedicated colleagues. You get plenty of room to develop yourself and show who you are. Furthermore, you can count on attractive employment conditions, such as:

• A competitive salary.

• 35.5 vacation days.

• 8% holiday allowance and 3% end-of-year bonus.

• Bonus scheme.

• An excellent pension.

• Various training modules and career growth opportunities.

Do you have questions about this vacancy?

Send your question including the vacancy number and the job title to the following email address: [email protected]. Applications can only be made via the website.

Required Skills:

Calibration of Equipment, Computerized Maintenance Management Systems (CMMS), Process Instrumentation, Protective Security, R&D Engineering

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/22/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.