Validation Engineer

Centre for Human Drug Research; Zuid-Holland; On-site; EUR 45,000 - 64,000; Full time

Benefits offered by this job

Pension ABP

Holiday allowance 8%

Year-end bonus 3.8–12%

25 vacation days + Diversity Day

Training & certifications

Transport cost reimbursement

Job summary

Centre for Human Drug Research in the Netherlands is seeking a Validation Engineer to manage validation projects for research equipment, including off-the-shelf and in-house devices. You will develop validation plans and support documentation to ensure equipment meets quality standards.

You will contribute to SOP development and perform Quality Control activities, collaborating with researchers, engineers, and QA to maintain GMP-compliant processes.

Qualifications

• Bachelor’s degree level or equivalent professional experience.
• Knowledge of and experience in GxP and GAMP5.
• Up-to-date knowledge of Good Clinical Practice and other applicable regulatory requirements.
• Affinity with research equipment.
• Strong general computer skills, including Word and Excel, with the ability to create and maintain clear, accurate, and consistently formatted technical documentation.
• Automation, scripting, or programming skills are useful, but not required.

Responsibilities

• Preparing and maintaining validation plans for new or modified research equipment.
• Supporting the definition of User Requirement Specifications (URS) and translating them into qualification protocols (IQ, OQ, and PQ).
• Coordinating and supporting equipment qualification, assessment, and configuration activities.
• Maintaining relevant SOPs and validation documentation and contributing to continuous improvement of validation processes.
• Collaborating with researchers, engineers, users, Quality Assurance, and technical support to ensure compliance with GMP regulatory standards.

Skills

GxP

GAMP5

Good Clinical Practice

Research equipment

Technical documentation

Word and Excel

Education

Bachelor’s degree or equivalent

Tools

Microsoft Word

Microsoft Excel

Job description

This position is only open to candidates who are currently residing in the Netherlands. Applications from candidates living outside the Netherlands will not be considered.

About the role

As a Validation Engineer, you will support validation processes for research equipment, including both off-the-shelf and in-house-developed equipment. You will be responsible for managing validation projects, including the development of validation plans and supporting the development of relevant validation documentation. You ensure that the equipment is thoroughly assessed and that it meets the required quality standards. You will contribute to the development and implementation of Standard Operating Procedures (SOPs) to ensure consistency, compliance, and efficient workflows. In addition, you will perform Quality Control activities on relevant processes, identifying opportunities for improvement and helping to maintain the high standards of CHDR’s research environment. Specifically, you will be responsible for:

• Preparing and maintaining validation plans for new or modified research equipment.
• Supporting the definition of User Requirement Specifications (URS) and translating them into qualification protocols (IQ, OQ, and PQ).
• Coordinating and supporting equipment qualification, assessment, and configuration activities.
• Maintaining relevant SOPs and validation documentation and contributing to continuous improvement of validation processes.
• Collaborating with researchers, engineers, users, Quality Assurance, and technical support to ensure compliance with GMP regulatory standards.

This is how CHDR supports you

At CHDR, you will receive a one-year contract for a minimum of 32 hours per week, with the possibility of a permanent position. You will work in a varied role within a professional and growing organisation, with plenty of opportunity to contribute your ideas. The main employment benefits (based on a 40-hour working week) include:

• A salary between €3,990 and €5,755, depending on your experience;
• A solid pension scheme through the ABP pension fund, 8% holiday allowance, and an end-of-year bonus ranging from a minimum of 3.8% up to a maximum of 12%, depending on the organisation’s results;
• 25 vacation days per year, plus one Diversity Day;
• Opportunities for personal development through training programmes and certifications;
• CHDR is easily accessible, with Leiden Central Station just a 10-minute walk away. Your public transport costs will be reimbursed up to 100%, and you have the option to purchase an (electric) bicycle at a discounted rate.

CHDR also contributes to a pleasant working environment by organising Friday afternoon drinks, an annual Christmas dinner, and a team outing to the Ardennes, which further strengthens the connection between colleagues. In addition, CHDR provides free access to OpenUp, an online platform focused on mental health, resilience, and personal development, offering masterclasses, group sessions, and one-on-one coaching conversations. This service is also available to family members.

What you bring to CHDR

We are looking for a disciplined and detail-oriented Validation Engineer who can plan and organise work effectively while managing multiple priorities. You have strong problem-solving skills and enjoy identifying practical, well-founded solutions to technical challenges. You remain calm and focused under pressure, enabling you to deliver high-quality work even in demanding situations. With a keen eye for detail and a commitment to accuracy, you ensure that validation activities are carried out thoroughly, consistently, and in compliance with applicable quality standards. Additionally, you bring:

• Bachelor’s degree level or equivalent professional experience.
• Knowledge of and experience in GxP and GAMP5.
• Up-to-date knowledge of Good Clinical Practice and other applicable regulatory requirements.
• Affinity with research equipment.
• Strong general computer skills, including proficiency in Microsoft Word and Excel, with the ability to create and maintain clear, accurate, and consistently formatted technical documentation.
• Automation, scripting, or programming skills are useful, but not required.

Interested?

Due to the holiday period, our recruitment process may take slightly longer than usual. We believe it is important to be transparent about this. The first interviews are scheduled for the week of September 21.