{"id":131866,"date":"2026-08-31T14:37:58","date_gmt":"2026-08-31T14:37:58","guid":{"rendered":"https:\/\/bhsg.com\/jobs\/job\/1408147_1788187078-senior-validation-engineer-indianapolis-indiana\/"},"modified":"2026-08-31T15:18:21","modified_gmt":"2026-08-31T15:18:21","slug":"1408147_1788187078-senior-validation-engineer-indianapolis-indiana","status":"publish","type":"job_listing","link":"https:\/\/bhsg.com\/jobs\/job\/1408147_1788187078-senior-validation-engineer-indianapolis-indiana\/","title":{"rendered":"Senior Validation Engineer"},"content":{"rendered":"<h4><strong><a id=\"myCustomID\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/1408147_1788187078\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n<\/p>\n<div>\n<h2>Position Overview<\/h2>\n<p>We are seeking an experienced <strong>Senior Validation Engineer<\/strong> to lead validation, qualification, and calibration activities supporting capital projects, manufacturing operations, laboratory systems, and regulated processes. This role will serve as a key technical resource responsible for ensuring equipment, utilities, computerized systems, and manufacturing processes meet regulatory, quality, and operational requirements.<\/p>\n<p>The ideal candidate will possess strong expertise in equipment qualification, process validation, computer system validation (CSV), calibration programs, and risk-based validation strategies within GMP-regulated environments. This individual will collaborate with Engineering, Quality, Manufacturing, Operations, and Regulatory teams to drive compliance and successfully execute critical projects.<\/p>\n<h2>Key Responsibilities<\/h2>\n<h3>Validation Strategy &amp; Project Execution<\/h3>\n<ul>\n<li>Lead validation activities from project planning through execution and final approval.<\/li>\n<li>Develop and maintain Validation Master Plans (VMPs), validation strategies, qualification plans, and validation lifecycle documentation.<\/li>\n<li>Author, review, and execute IQ, OQ, and PQ protocols, test scripts, validation reports, and traceability matrices.<\/li>\n<li>Support capital expansion, facility upgrades, equipment installations, and process improvement initiatives.<\/li>\n<\/ul>\n<h3>Equipment Qualification &amp; Calibration<\/h3>\n<ul>\n<li>Lead qualification and calibration activities for manufacturing equipment, laboratory instruments, utilities, and facility systems.<\/li>\n<li>Ensure calibration programs maintain compliance with internal procedures and industry standards.<\/li>\n<li>Oversee calibration documentation, traceability requirements, and record management.<\/li>\n<li>Support commissioning and qualification efforts for new equipment and systems.<\/li>\n<\/ul>\n<h3>Computer System Validation (CSV)<\/h3>\n<ul>\n<li>Execute and support validation efforts for computerized systems including:\n<ul>\n<li>SCADA<\/li>\n<li>DCS<\/li>\n<li>MES<\/li>\n<li>LIMS<\/li>\n<li>Data Historians<\/li>\n<li>Laboratory Software Systems<\/li>\n<\/ul>\n<\/li>\n<li>Ensure compliance with GAMP 5, 21 CFR Part 11, and Data Integrity requirements.<\/li>\n<\/ul>\n<h3>Risk Assessment &amp; Change Management<\/h3>\n<ul>\n<li>Conduct risk assessments utilizing FMEA, impact assessments, and criticality analyses.<\/li>\n<li>Evaluate changes to equipment, processes, facilities, and software systems to determine validation requirements.<\/li>\n<li>Apply risk-based validation principles in accordance with ASTM E2500 and ICH guidelines.<\/li>\n<\/ul>\n<h3>Compliance &amp; Regulatory Support<\/h3>\n<ul>\n<li>Ensure validation and qualification activities comply with:\n<ul>\n<li>FDA regulations<\/li>\n<li>cGMP requirements<\/li>\n<li>21 CFR Parts 210, 211, and Part 11<\/li>\n<li>ASTM E2500<\/li>\n<li>ICH Q7, Q8, Q9, and Q10<\/li>\n<li>GAMP 5<\/li>\n<\/ul>\n<\/li>\n<li>Support regulatory inspections, customer audits, and internal quality audits.<\/li>\n<li>Prepare validation documentation packages and provide technical responses during inspections.<\/li>\n<\/ul>\n<h3>Cross-Functional Collaboration<\/h3>\n<ul>\n<li>Partner with Engineering, Manufacturing, Quality Assurance, QC, Operations, Automation, IT, and Regulatory Affairs teams.<\/li>\n<li>Coordinate validation activities with project schedules and business priorities.<\/li>\n<li>Provide technical guidance and mentorship to junior engineers and validation personnel.<\/li>\n<\/ul>\n<h3>Continuous Improvement<\/h3>\n<ul>\n<li>Identify and implement improvements to validation and calibration programs.<\/li>\n<li>Drive standardization of validation processes, templates, and best practices.<\/li>\n<li>Support initiatives focused on efficiency, compliance, and operational excellence.<\/li>\n<\/ul>\n<h2>Required Qualifications<\/h2>\n<ul>\n<li>Bachelor&#8217;s degree in Engineering, Life Sciences, Chemistry, or a related technical discipline.<\/li>\n<li>5+ years of experience in validation, qualification, calibration, or commissioning within pharmaceutical, biotechnology, medical device, or other GMP-regulated environments.<\/li>\n<li>Strong understanding of:\n<ul>\n<li>cGMP regulations<\/li>\n<li>FDA requirements<\/li>\n<li>ASTM E2500<\/li>\n<li>ICH guidelines<\/li>\n<li>GAMP 5<\/li>\n<li>21 CFR Part 11<\/li>\n<li>Data Integrity principles<\/li>\n<\/ul>\n<\/li>\n<li>Experience authoring and executing IQ\/OQ\/PQ protocols and validation reports.<\/li>\n<li>Experience supporting equipment qualification, utilities validation, and manufacturing systems.<\/li>\n<li>Excellent technical writing, communication, and project management skills.<\/li>\n<\/ul>\n<h2>Preferred Qualifications<\/h2>\n<ul>\n<li>Experience supporting large-scale CAPEX projects.<\/li>\n<li>Experience with aseptic manufacturing, sterile processing, biologics, or advanced therapy manufacturing.<\/li>\n<li>Experience with process validation, cleaning validation, and CSV programs.<\/li>\n<li>Familiarity with validation management platforms such as Kneat or ValGenesis.<\/li>\n<li>Experience with electronic quality systems such as MasterControl, Veeva, or TrackWise.<\/li>\n<li>Knowledge of calibration standards, uncertainty analysis, and metrology principles.<\/li>\n<li>ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant certifications.<\/li>\n<li>Proven history of supporting successful FDA and regulatory inspections.<\/li>\n<\/ul>\n<\/div>\n<p><img decoding=\"async\" src=\"https:\/\/counter.adcourier.com\/cGhhcm1haW5wLjAwNzk2LjEyNTg0QGJlYWNvbmhpbGwuYXBsaXRyYWsuY29t.gif\"><\/p>\n<p><span style=\"color: #ffffff;\">1408147_1788187078<\/span><\/p>\n<h4><strong><a id=\"otherId\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/1408147_1788187078\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n","protected":false},"author":0,"featured_media":3770,"template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","inline_featured_image":false,"_promoted":"","_job_location":"Indianapolis, Indiana","_application":"pharmainp.00796.12584@beaconhill.aplitrak.com","_company_name":"Beacon Hill Staffing 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