{"schemaVersion":"jobsearcher.job.v1","id":"850d486173c01f43d9ed74a8","url":"https://jobsearcher.com/jobs/850d486173c01f43d9ed74a8","canonicalUrl":"https://jobsearcher.com/jobs/850d486173c01f43d9ed74a8","title":"Engineering - Validation Engineer","description":"Hybrid Role- 50% onsite minimum required\nPosition Overview:\nThe CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.\nEssential Functions:\nMaintains all qualified and validated equipment and systems in compliance with policies, guidelines, and procedures.\nDevelops protocols and associated reports while adhering to a change management process.\nSupports the execution of equipment qualifications and validation protocols.\nSupervises vendors for qualification functions.\nSupports equipment qualification and systems validation activities.\nConfigures and documents the configuration of computerized systems.\nDevelops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.\nManages projects of varying scope and complexity.\nSupports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to business area.\nIndependent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.\nSupports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.\nCompletes all qualification and validation documentation with accuracy, completeness, and compliance to Company standards.\nProvides excellent customer service and support.\nRegularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.\nProvides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.\nMaintains a positive relationship with all team members and site customers while promoting a positive team environment.\nRequired Competencies-Knowledge, Skills, and Abilities:\nStrong working knowledge of MS Windows client and server technologies.\nWorking knowledge of standard networking principles and technologies.\nExcellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.\nStrong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.\nAbility to work with the end user to identify and document User and Functional Requirements.\nKnowledge of pharmaceutical laboratory and manufacturing systems.\nExperience executing equipment qualification documents.\nAbility to interact effectively with laboratory, QA, and Facilities groups.\nStrong ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.\nStrong written and verbal communication skills along with solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors, and vendors. Experience with technical writing and document development/generation.\nStrong computer skills in Microsoft Office Suite Word, Excel, Visio, and Outlook, and the ability to learn new software as required for equipment qualification.\nCompetencies:\nTechnical / Professional Knowledge\nProblem Solving / Troubleshooting\nAction Oriented\nAttention to Detail\nMulti-tasking\nBuilding Relationships\nEducation & Experience:\nBS degree in Engineering / Computer Science or equivalent experience (degree not required). Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV.\nWorking Conditions:\nEnvironmental Conditions: Environment may include working in office or in a laboratory/manufacturing area. Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste. Ability to work safely when working alone, or working with others.\n\n#J-18808-Ljbffr","company":"TechDigital Group","rawCompany":"techdigital group","city":"Summit","state":"NJ","isRemote":false,"isActive":true,"createdAt":"2026-06-20T04:01:00.143Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-3028.00","title":"Calibration Technologists and Technicians","slug":"calibration-technologists-and-technicians"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Engineering - Validation Engineer","description":"Hybrid Role- 50% onsite minimum required\nPosition Overview:\nThe CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.\nEssential Functions:\nMaintains all qualified and validated equipment and systems in compliance with policies, guidelines, and procedures.\nDevelops protocols and associated reports while adhering to a change management process.\nSupports the execution of equipment qualifications and validation protocols.\nSupervises vendors for qualification functions.\nSupports equipment qualification and systems validation activities.\nConfigures and documents the configuration of computerized systems.\nDevelops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.\nManages projects of varying scope and complexity.\nSupports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to business area.\nIndependent ownership of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.\nSupports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.\nCompletes all qualification and validation documentation with accuracy, completeness, and compliance to Company standards.\nProvides excellent customer service and support.\nRegularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.\nProvides technical support and guidance on calibration and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.\nMaintains a positive relationship with all team members and site customers while promoting a positive team environment.\nRequired Competencies-Knowledge, Skills, and Abilities:\nStrong working knowledge of MS Windows client and server technologies.\nWorking knowledge of standard networking principles and technologies.\nExcellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.\nStrong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.\nAbility to work with the end user to identify and document User and Functional Requirements.\nKnowledge of pharmaceutical laboratory and manufacturing systems.\nExperience executing equipment qualification documents.\nAbility to interact effectively with laboratory, QA, and Facilities groups.\nStrong ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.\nStrong written and verbal communication skills along with solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors, and vendors. Experience with technical writing and document development/generation.\nStrong computer skills in Microsoft Office Suite Word, Excel, Visio, and Outlook, and the ability to learn new software as required for equipment qualification.\nCompetencies:\nTechnical / Professional Knowledge\nProblem Solving / Troubleshooting\nAction Oriented\nAttention to Detail\nMulti-tasking\nBuilding Relationships\nEducation & Experience:\nBS degree in Engineering / Computer Science or equivalent experience (degree not required). Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV.\nWorking Conditions:\nEnvironmental Conditions: Environment may include working in office or in a laboratory/manufacturing area. Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste. Ability to work safely when working alone, or working with others.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T04:01:00.143Z","dateModified":"2026-06-20T04:01:00.143Z","hiringOrganization":{"@type":"Organization","name":"TechDigital Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Summit","addressRegion":"NJ","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"850d486173c01f43d9ed74a8"},"url":"https://jobsearcher.com/jobs/850d486173c01f43d9ed74a8"}}