{"schemaVersion":"jobsearcher.job.v1","id":"4984220d574d6f50f5133c01","url":"https://jobsearcher.com/jobs/4984220d574d6f50f5133c01","canonicalUrl":"https://jobsearcher.com/jobs/4984220d574d6f50f5133c01","title":"Validation Engineer","description":"100% Onsite position\n\nPURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. 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.\n\nREQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.\nExperience in the qualification of cell therapy equipment a plus.\nAdvanced knowledge of pharmaceutical, manufacturing and laboratory systems.\nUnderstanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.\nStrong written and verbal communication skills.\nExcellent interpersonal skills with experience dealing with a diverse workforce.\nStrong multitasking ability in conjunction with proven organizational skills. 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.\nHighly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.\n\nEducation and Experience: BS in Engineering or Science related discipline required.\nMinimum of 5 years' experience performing/supporting activities in a GMP environment.\nMinimum of 3 years' experience in equipment, facility or utility qualification.\n\nDUTIES AND RESPONSIBILITIES: Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification 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.\nDevelops written procedures for calibration and preventive maintenance of equipment.\nSupports equipment qualification and validation activities.\nDevelops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.\n\nManages projects of limited scope and complexity within their functional area: Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.\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 Client standards.\n\nProvides excellent customer service and support: Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.\nProvides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.\nProvides technical support and guidance on equipment and computer systems qualification and validations issues.\nMaintains a positive relationship with all team members and site customers while promoting a positive team environment.\n\nRegulatory Responsibilities: Ensure equipment, facilities and programs are maintained in compliance.\nMay be called upon as SME in both internal and regulatory audits.\n\nWORKING CONDITIONS (US Only): Physical / Mental Demands: Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.\nAbility to sit, stand, walk and move within workspace for extended periods.\nAbility to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.\nEnvironmental Conditions: Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.\nAbility to work safely and effectively 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":"2026-06-20T04:44:07.463Z","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":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"334516","title":"Analytical Laboratory Instrument Manufacturing","slug":"analytical-laboratory-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"100% Onsite position\n\nPURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. 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.\n\nREQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.\nExperience in the qualification of cell therapy equipment a plus.\nAdvanced knowledge of pharmaceutical, manufacturing and laboratory systems.\nUnderstanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.\nStrong written and verbal communication skills.\nExcellent interpersonal skills with experience dealing with a diverse workforce.\nStrong multitasking ability in conjunction with proven organizational skills. 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.\nHighly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.\n\nEducation and Experience: BS in Engineering or Science related discipline required.\nMinimum of 5 years' experience performing/supporting activities in a GMP environment.\nMinimum of 3 years' experience in equipment, facility or utility qualification.\n\nDUTIES AND RESPONSIBILITIES: Maintains qualified equipment systems in compliance with policies, guidelines and procedures: Develops qualification 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.\nDevelops written procedures for calibration and preventive maintenance of equipment.\nSupports equipment qualification and validation activities.\nDevelops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.\n\nManages projects of limited scope and complexity within their functional area: Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.\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 Client standards.\n\nProvides excellent customer service and support: Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.\nProvides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.\nProvides technical support and guidance on equipment and computer systems qualification and validations issues.\nMaintains a positive relationship with all team members and site customers while promoting a positive team environment.\n\nRegulatory Responsibilities: Ensure equipment, facilities and programs are maintained in compliance.\nMay be called upon as SME in both internal and regulatory audits.\n\nWORKING CONDITIONS (US Only): Physical / Mental Demands: Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.\nAbility to sit, stand, walk and move within workspace for extended periods.\nAbility to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.\nEnvironmental Conditions: Primarily office environment, but will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.\nAbility to work safely and effectively when working alone, or working with others.\n\n#J-18808-Ljbffr","datePosted":"2026-06-20T04:44:07.463Z","dateModified":"2026-06-20T04:44:07.463Z","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":"4984220d574d6f50f5133c01"},"url":"https://jobsearcher.com/jobs/4984220d574d6f50f5133c01"}}