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(Sr) Validation Engineer

General information

(Sr) Validation Engineer

With our growing Validation Team, a great opportunity for a (Senior) Validation Engineer has become available at HAL Allergy in Leiden!

As (Senior)Validation Engineer , you play a vital role in ensuring compliance with regulatory standards and industry best practices throughout the qualification and validation processes. You work closely with cross-functional teams and play a crucial role by coordinating, planning, executing, reporting and archiving qualification / validation.

Your tasks

• Provide expert validation input in the design, implementation, and modification of equipment, systems, and production facilities.
• Co-develop and assess User Requirement Specifications (URS) in collaboration with multidisciplinary teams and suppliers.
• Prepare and execute C&Q/IQ/OQ/PQ protocols for equipment, utilities, processes, cleaning, and computer systems, including reporting and validation frequency recommendations.
• Write and maintain process and cleaning validation protocols and periodic validation reports for critical systems.
• Draft, review, and update validation procedures, the Validation Master Plan (VMP), and other controlled documents (e.g. SOPs) to ensure accuracy and compliance.
• Conduct risk assessments and advise on risk mitigation strategies related to qualification and validation.
• Collaborate with Engineering, Manufacturing, and Quality teams to ensure compliance with GMP and Good Documentation Practices (GDocP).
• Investigate deviations and non-conformances, and implement corrective and preventive actions (CAPAs).

You have

• HBO or Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
• 5 to 10 years relevant validation experience.
• Demonstrated track record as a validation specialist, particularly in qualification and validation within the pharmaceutical sector.
• Profound comprehension of GMP regulations and industry standards.
• Knowledge of qualification and validation procedures for equipment, facilities, utilities, computer systems, manufacturing processes, and analytical methods.
• Proficient in quality systems, documentation practices, and risk assessment methods.
• Skilled in deviation and CAPA management, root cause analysis, and change control processes.
• Meticulous attention to detail, analytical reasoning, and problem-solving abilities.
• Strong communication and interpersonal skills for effective collaboration with diverse teams.
• Good command of the Dutch and English language, both verbally and in writing

Who are we looking for?

You are a practical, detail-oriented professional who enjoys working close to the process. With a hands-on mindset, you translate complex validation requirements into clear, compliant solutions. You take ownership from protocol to execution, ensuring all systems and equipment meet GMP standards.

Collaborative and structured, you connect easily with colleagues from various departments. You balance regulatory rigor with a pragmatic approach and deliver reliable results under pressure.

Our offer

• You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
• A culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient's well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
• You will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production.
• Being part of a company that is geared towards helping people live happier and healthier lives.
• A competitive salary that matches your responsibilities and experience.
• A 13th month salary
• 30 leave days.
• Company contribution to a pension package and health insurance.

Your application

We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.

Important notice to search firms and recruitment agencies

HAL Allergy does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HAL Allergy Recruitment via to enquire about a potential recruitment or search agreement with HAL Allergy.

HAL Allergy, for those who seek pharmaceutical innovation

HAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity!

HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health.