Jobs → Engineering → Validation Engineer

About the Role We are actively looking for an experienced Validation Engineer to join our team in the USA. The ideal candidate will have hands-on experience in validation activities, quality systems, regulatory compliance, and validation documentation. Key Responsibilities • Develop and execute validation protocols, including IQ, OQ, and PQ • Perform equipment, process, cleaning, and manufacturing validation • Prepare and review validation reports, protocols, and technical documentation • Ensure compliance with FDA 21 CFR Part 11, 21 CFR Part 820, and applicable GMP regulations • Support computer system validation (CSV) and software validation activities • Perform risk assessments and support change control processes • Investigate deviations, discrepancies, and validation failures • Work with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering • Support internal and external audits • Ensure compliance with ISO 13485, FDA, and applicable regulatory requirements Requirements • Bachelor's degree in Engineering, Life Sciences, or a related field • 3+ years of experience in Validation Engineering • Strong knowledge of IQ/OQ/PQ, GMP, and FDA regulations • Experience with validation documentation and quality management systems • Knowledge of CAPA, deviations, change control, and risk management • Excellent communication and documentation skills Preferred Skills • Medical Device or Pharmaceutical industry experience • Experience with TrackWise, Veeva, MasterControl, or similar QMS tools • Knowledge of GAMP 5 and ISO 13485 • Experience with equipment and process validation