CQV Validation Engineer

Position OverviewWe are currently hiring Validation Engineers to support the expansion of manufacturing operations at a highly regulated medical device production facility. These positions will play a key role in qualifying new production equipment, ensuring manufacturing processes meet regulatory and quality standards, and supporting the successful launch of newly installed manufacturing lines.The ideal candidate has practical experience executing equipment and process validation activities within a regulated environment and is comfortable working on multiple validation projects while maintaining high-quality documentation.Primary ResponsibilitiesLead and execute equipment qualification and process validation activities for new manufacturing systems.Prepare, review, and execute validation documentation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.Support qualification efforts for production equipment such as automated assembly systems, filling equipment, inspection machines, labeling systems, and final packaging equipment.Perform qualification and temperature mapping activities for controlled storage environments, including refrigerators, freezers, and other temperature-controlled units.Collaborate with Engineering, Manufacturing, Quality Assurance, and Regulatory teams during equipment installation, commissioning, and production readiness.Participate in risk assessments, process evaluations, and continuous improvement initiatives to ensure compliance with validation requirements.Investigate validation discrepancies, document deviations, and support CAPA implementation as needed.Maintain accurate validation records while ensuring compliance with internal quality procedures and regulatory expectations.Assist with equipment lifecycle documentation and support project milestones throughout capital expansion activities.Required QualificationsBachelor's degree in Engineering, Life Sciences, or a related technical discipline.Minimum of 3 years of experience performing validation activities within the medical device, pharmaceutical, biotechnology, or other FDA-regulated manufacturing industries.Strong working knowledge of the complete validation lifecycle, including protocol development, execution, data analysis, and final reporting for IQ, OQ, and PQ.Hands-on experience qualifying manufacturing equipment used in automated production, filling operations, inspection, labeling, or packaging processes.Experience validating temperature-controlled equipment, including calibration support, environmental mapping, and qualification of cold storage systems.Solid understanding of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable FDA quality system regulations, including 21 CFR Part 820.Experience performing risk-based validation activities using methodologies such as FMEA.Familiarity with deviation investigations, change control processes, and CAPA systems.Strong technical writing skills with the ability to produce clear, compliant validation documentation.Excellent interpersonal and communication skills with experience working across multidisciplinary project teams.Experience using electronic Quality Management Systems (eQMS) or document control platforms is considered an advantage.