About this role
(Sr) Validation Engineer General information (Sr) Validation Engineer Leiden (NL) | 40-36 hrs This role is based in the Netherlands. Applicants must be eligible to work in the Netherlands. 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,...