Jobid=6317553d167f (0.1044)
(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
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