{"schemaVersion":"jobsearcher.job.v1","id":"4a3ac99497edfb60550e6f2e","url":"https://jobsearcher.com/jobs/4a3ac99497edfb60550e6f2e","canonicalUrl":"https://jobsearcher.com/jobs/4a3ac99497edfb60550e6f2e","title":"Process Validation Engineer/Manufacturing Engineer - Medical Device","description":"Job Title: Senior Process Validation EngineerLocation: Raynham, MA (Onsite Local candidates preferred)Type: Contract (1 year + long-term extensions)Industry: Medical Device Manufacturing | Supply Chain QualityJob SummaryWe are seeking a Senior Process Validation Engineer to support the startup and qualification of a new Class III medical device manufacturing facility. This role will be part of the Supply Chain Quality team and will lead critical validation and quality activities to ensure compliant and efficient manufacturing operations.The ideal candidate will bring strong expertise in process validation, equipment qualification, and inspection readiness, working closely with cross-functional teams in a highly regulated environment.Key ResponsibilitiesLead process qualification and validation activities to ensure manufacturing processes are robust and compliantPlan and execute IQ, OQ, PQ, and process validation activitiesDevelop validation strategies, protocols, reports, and documentation (including URS)Support inspection readiness by ensuring Critical-to-Quality (CTQ) characteristics are verified using qualified methodsPerform test method validation and measurement system analysis (e.g., Gauge R&R)Provide Quality oversight for validation documentation and approvalsSupport deviation investigations, root cause analysis, and troubleshootingCollaborate with Manufacturing, Engineering, Supply Chain, and R&D teams to meet project timelinesRequired Qualifications5+ years of hands-on experience in process validation within regulated environments (GMP/ISO)4+ years of experience in Quality, Supply Chain, or R&D within medical devices or similar industriesStrong expertise in IQ/OQ/PQ, process verification, and validation documentationExperience with CNC machining processes and Coordinate Measuring Machines (CMM)Experience in risk management (FMEA)Strong communication, collaboration, and project management skills","company":"Stark Pharma Solutions","rawCompany":"stark pharma solutions","city":"Raynham","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-06-07T09:27:37.703Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Validation Engineer/Manufacturing Engineer - Medical Device","description":"Job Title: Senior Process Validation EngineerLocation: Raynham, MA (Onsite Local candidates preferred)Type: Contract (1 year + long-term extensions)Industry: Medical Device Manufacturing | Supply Chain QualityJob SummaryWe are seeking a Senior Process Validation Engineer to support the startup and qualification of a new Class III medical device manufacturing facility. This role will be part of the Supply Chain Quality team and will lead critical validation and quality activities to ensure compliant and efficient manufacturing operations.The ideal candidate will bring strong expertise in process validation, equipment qualification, and inspection readiness, working closely with cross-functional teams in a highly regulated environment.Key ResponsibilitiesLead process qualification and validation activities to ensure manufacturing processes are robust and compliantPlan and execute IQ, OQ, PQ, and process validation activitiesDevelop validation strategies, protocols, reports, and documentation (including URS)Support inspection readiness by ensuring Critical-to-Quality (CTQ) characteristics are verified using qualified methodsPerform test method validation and measurement system analysis (e.g., Gauge R&R)Provide Quality oversight for validation documentation and approvalsSupport deviation investigations, root cause analysis, and troubleshootingCollaborate with Manufacturing, Engineering, Supply Chain, and R&D teams to meet project timelinesRequired Qualifications5+ years of hands-on experience in process validation within regulated environments (GMP/ISO)4+ years of experience in Quality, Supply Chain, or R&D within medical devices or similar industriesStrong expertise in IQ/OQ/PQ, process verification, and validation documentationExperience with CNC machining processes and Coordinate Measuring Machines (CMM)Experience in risk management (FMEA)Strong communication, collaboration, and project management skills","datePosted":"2026-06-07T09:27:37.703Z","dateModified":"2026-06-07T09:27:37.703Z","hiringOrganization":{"@type":"Organization","name":"Stark Pharma Solutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Raynham","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"4a3ac99497edfb60550e6f2e"},"url":"https://jobsearcher.com/jobs/4a3ac99497edfb60550e6f2e"}}