{"schemaVersion":"jobsearcher.job.v1","id":"5fee871115435f1f2b45899b","url":"https://jobsearcher.com/jobs/5fee871115435f1f2b45899b","canonicalUrl":"https://jobsearcher.com/jobs/5fee871115435f1f2b45899b","title":"Validation Engineer","description":"If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.\n\nValidation Engineer\nFull Time FL, Ruskin, FL, US\n\n6 days ago Requisition ID: 1200\n\nCompany Overview\n\nB&M Precision is an FDA-registered and ISO 13485 certified medical device contract manufacturer committed to producing safe, compliant, and high-quality products. Our quality culture is grounded in robust processes, data-driven decision-making, and continuous improvement.\n\nPosition Summary\n\nThe Validation Engineer ensures that systems, processes, and equipment meet validation requirements and comply with internal procedures and external standards. This role involves developing validation protocols, performing risk assessments, analyzing test data, producing validation reports, and supporting production activities to maintain product quality and operational efficiency.\n\nThis is not a remote position\n\nKey Responsibilities:\n\nDevelop and maintain master validation plans, risk assessments, testing protocols, and related standard operating procedures (SOPs).\n\nAnalyze validation test data to confirm compliance with validation criteria and identify root causes for any issues.\n\nPrepare detailed reports and design statements based on validation and qualification test results.\n\nConduct validation and qualification tests for new or existing processes, equipment, and software in accordance with internal procedures and regulatory standards.\n\nCommunicate effectively with customers to address validation-related inquiries and provide updates.\n\nRecommend process changes to improve product quality and operational performance.\n\nMeasure product and process performance using customer-provided standards or metrics; perform tests and analyze data to ensure compliance.\n\nB&M Specific Responsibilities:\n\nPerform Process Capability Analysis and Process Failure Mode and Effects Analysis (pFMEA).\n\nConduct Risk Assessments for processes and equipment.\n\nDevelop and execute Equipment Installation and Operational Qualification (EIQ/EOQ) activities.\n\nPerform Process Characterization studies using tools such as DOEs and fishbone diagrams.\n\nDevelop robust control strategies for process variables.\n\nCreate and revise Control Plans to ensure process stability.\n\nDevelop and conduct Measurement Systems Analysis (MSA) studies.\n\nPerform Process Operational and Performance Qualification (OQ/PQ) activities.\n\nAssist in development of manufacturing equipment and processes to achieve validation requirements.\n\nExecute Verifiable Process Qualification activities.\n\nDevelop and maintain in-process and final inspection datasheets, Certificates of Conformance (C of Cs), and Certificates of Analysis (C of As).\n\nCreate and review Work Instructions (WI), Preventive Maintenance Plans (PMP), and Standard Operating Procedures (SOPs).\n\nReview and approve Engineering Change Orders (ECOs).\n\nTrain other members of the Engineering Team on processes and standards.\n\nProvide production support for Laser Welding, Laser Marking, Electropolish, Passivation, Final Cleaning, and Final Inspection.\n\nReview and approve Engineering Drawings.\n\nSupport New Product Development (NPD) activities.\n\nCommunicate regularly with customers regarding projects, deadlines, and action items.\n\nQualifications:\n\nBachelor’s degree in engineering, quality assurance, or related field (or equivalent experience).\n\nAdvanced degrees in engineering-related fields are preferred but not required.\n\nStrong knowledge of validation principles, risk analysis, and quality systems.\n\nExperience with validation of laser processes, cleaning processes, and special manufacturing techniques preferred.\n\nExcellent analytical, documentation, and communication skills.\n\nExperience in medical device manufacturing and ISO 13485 preferred.\n\nWhy Join B&M Precision\n\nFamily-owned organization with a strong quality culture.\n\nPaid vacation, holidays, and PTO.\n\nAnnual bonus, profit sharing, and 401(k) with company match.\n\n#J-18808-Ljbffr","company":"Bm Precision","rawCompany":"bm precision","city":"Ruskin","state":"FL","isRemote":false,"isActive":false,"createdAt":"2026-06-17T03:31:34.113Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"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":"Validation Engineer","description":"If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.\n\nValidation Engineer\nFull Time FL, Ruskin, FL, US\n\n6 days ago Requisition ID: 1200\n\nCompany Overview\n\nB&M Precision is an FDA-registered and ISO 13485 certified medical device contract manufacturer committed to producing safe, compliant, and high-quality products. Our quality culture is grounded in robust processes, data-driven decision-making, and continuous improvement.\n\nPosition Summary\n\nThe Validation Engineer ensures that systems, processes, and equipment meet validation requirements and comply with internal procedures and external standards. This role involves developing validation protocols, performing risk assessments, analyzing test data, producing validation reports, and supporting production activities to maintain product quality and operational efficiency.\n\nThis is not a remote position\n\nKey Responsibilities:\n\nDevelop and maintain master validation plans, risk assessments, testing protocols, and related standard operating procedures (SOPs).\n\nAnalyze validation test data to confirm compliance with validation criteria and identify root causes for any issues.\n\nPrepare detailed reports and design statements based on validation and qualification test results.\n\nConduct validation and qualification tests for new or existing processes, equipment, and software in accordance with internal procedures and regulatory standards.\n\nCommunicate effectively with customers to address validation-related inquiries and provide updates.\n\nRecommend process changes to improve product quality and operational performance.\n\nMeasure product and process performance using customer-provided standards or metrics; perform tests and analyze data to ensure compliance.\n\nB&M Specific Responsibilities:\n\nPerform Process Capability Analysis and Process Failure Mode and Effects Analysis (pFMEA).\n\nConduct Risk Assessments for processes and equipment.\n\nDevelop and execute Equipment Installation and Operational Qualification (EIQ/EOQ) activities.\n\nPerform Process Characterization studies using tools such as DOEs and fishbone diagrams.\n\nDevelop robust control strategies for process variables.\n\nCreate and revise Control Plans to ensure process stability.\n\nDevelop and conduct Measurement Systems Analysis (MSA) studies.\n\nPerform Process Operational and Performance Qualification (OQ/PQ) activities.\n\nAssist in development of manufacturing equipment and processes to achieve validation requirements.\n\nExecute Verifiable Process Qualification activities.\n\nDevelop and maintain in-process and final inspection datasheets, Certificates of Conformance (C of Cs), and Certificates of Analysis (C of As).\n\nCreate and review Work Instructions (WI), Preventive Maintenance Plans (PMP), and Standard Operating Procedures (SOPs).\n\nReview and approve Engineering Change Orders (ECOs).\n\nTrain other members of the Engineering Team on processes and standards.\n\nProvide production support for Laser Welding, Laser Marking, Electropolish, Passivation, Final Cleaning, and Final Inspection.\n\nReview and approve Engineering Drawings.\n\nSupport New Product Development (NPD) activities.\n\nCommunicate regularly with customers regarding projects, deadlines, and action items.\n\nQualifications:\n\nBachelor’s degree in engineering, quality assurance, or related field (or equivalent experience).\n\nAdvanced degrees in engineering-related fields are preferred but not required.\n\nStrong knowledge of validation principles, risk analysis, and quality systems.\n\nExperience with validation of laser processes, cleaning processes, and special manufacturing techniques preferred.\n\nExcellent analytical, documentation, and communication skills.\n\nExperience in medical device manufacturing and ISO 13485 preferred.\n\nWhy Join B&M Precision\n\nFamily-owned organization with a strong quality culture.\n\nPaid vacation, holidays, and PTO.\n\nAnnual bonus, profit sharing, and 401(k) with company match.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:31:34.113Z","dateModified":"2026-06-17T03:31:34.113Z","hiringOrganization":{"@type":"Organization","name":"Bm Precision","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Ruskin","addressRegion":"FL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"5fee871115435f1f2b45899b"},"url":"https://jobsearcher.com/jobs/5fee871115435f1f2b45899b"}}