We are seeking an experienced validation engineer to support validation activities for medical device manufacturing processes, equipment, test methods, and systems. The role requires strong hands-on expertise in iq/oq/pq execution and compliance with global medical device regulations.
key responsibilities
* develop, review, and execute iq/oq/pq protocols for manufacturing equipment and processes
* perform process validation and test method validation (tmv)
* support computerized system validation (csv) where applicable
* author validation plans, protocols, reports, and traceability documentation
* conduct risk assessments and support pfmea activities
* investigate deviations and support capa implementation
* ensure compliance with design controls and validation lifecycle requirements
* collaborate with quality, manufacturing, r&d, regulatory, and supply chain teams
* support audits and regulatory inspections
required qualifications
* bachelor's degree in engineering or related technical field
* experience in medical device validation or regulated manufacturing
* strong hands-on experience with iq/oq/pq execution
* knowledge of process validation and tmv
* familiarity with fda 21 cfr part 820, iso 13485, and iso 14971
* experience with change control, deviations, and capa processes
* strong documentation and technical writing skills
preferred qualifications
* experience with class ii or class iii medical devices
* knowledge of software or computerized system validation (csv)
* familiarity with statistical tools (minitab, spc, etc.)
* ability to manage multiple validation projects
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