{"schemaVersion":"jobsearcher.job.v1","id":"4f12c020fe6b1f8c644fae86","url":"https://jobsearcher.com/jobs/4f12c020fe6b1f8c644fae86","canonicalUrl":"https://jobsearcher.com/jobs/4f12c020fe6b1f8c644fae86","title":"Validation Engineer","description":"Job Description: 100% Onsite position\nPURPOSE AND SCOPE OF POSITION:\nThe Equipment Validation Engineer supports the successful implementation of various process/lab\nequipment at multi-use sites through interaction with internal customers and external service\nproviders. The incumbent in this is tasked with commissioning and qualifying new equipment\nfacilities, utilities and maintaining equipment systems in a qualified / validated state according to\nestablished policies and procedures. The individual participates in projects and ongoing work\nactivities of low to moderate complexity. With minimum supervision and given general\ninstructions, this individual carries out routine tasks and functions, and uses basic analytical skills\nto recognize and solve common problems of limited scope. As a developing team player, the\nincumbent interacts with their immediate supervisor and personnel within their own work group\nto achieve team goals while building trust and collaborative relationships outside the immediate\norganization.\nREQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:\nKnowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer\nsystems 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\npharmaceutical industry.\nStrong written and verbal communication skills.\nExcellent interpersonal skills with experience dealing with a diverse workforce.\nStrong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize\nassigned tasks in a high paced environment and concurrently monitor tasks / assignmentswith others that may impact timely completion. Ability to effectively manage multiple tasksand activities simultaneously.\nHighly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and\nOutlook with extensive background in database systems. Innate ability to learn new software,such as corporate intranet and enterprise business.Education and Experience:\nBS in Engineering or Science related discipline required\nMinimum of 5 years’ experience performing/supporting activities in\na GMP environment.\nMinimum of 3 years’ experience in equipment, facility or utility\nqualificationDUTIES AND RESPONSIBILITIES:\n1) Maintains qualified equipment systems in compliance with policies, guidelines and procedures:\na. Develops qualification protocols, and associated reports while adhering to a change\nmanagement process.\nb. Supports the execution of equipment qualifications and validation protocols.\nc. Supervises vendors for qualification functions.\nd. Develops written procedures for calibration and preventive maintenance of equipment.\ne. Supports equipment qualification and validation activities.\nf. Develops validation/qualification deliverables such as Validation Plans, Requirements\nSpecifications, Traceability Matrices, Summary Reports, Change Controls.\n2) Manages projects of limited scope and complexity within their functional area:\na. Supports equipment implementation projects including scheduling, procurement, site prep,\ninstallation, qualification, and turn over to business area.\nb. Supports internal customer groups in the procurement, operation, calibration, and\npreventive maintenance of equipment to meet business needs in accordance with required\nschedules or dates.\nc. Completes all qualification and validation documentation with accuracy, completeness and\ncompliance to Client standards.\n3) Provides excellent customer service and support:\na. Regularly reviews, prioritizes and promptly responds to customer equipment qualification\nand support requests.\nb. Provides technical support and guidance on equipment qualification issues. Interfaces with\ncustomers to ensure all expectations are being met.\nc. Provides technical support and guidance on equipment and computer systems qualification\nand validations issues.\nd. Maintains a positive relationship with all team members and site customers while promoting\na positive team environment.\n4) Regulatory Responsibilities\na. Ensure equipment, facilities and programs are maintained in compliance.\nb. May be called upon as SME in both internal and regulatory audits.\nWORKING CONDITIONS (US Only):\nPhysical / Mental Demands:\nOccasional 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\npulling.Environmental Conditions:\nPrimarily office environment, but will be required to enter laboratory or GMP process areas\ndonning 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.\nJob Type: Contract\nPay: $60.00 - $75.00 per hour\nSchedule:\n8 hour shift\nAbility to commute/relocate:\nBothell, WA 98021: Reliably commute or planning to relocate before starting work (Required)\nExperience:\nEquipment Validation: 3 years (Required)\nComputer System Validation: 5 years (Required)\nCGMP: 6 years (Required)\nWork Location: In person","company":"Eclaro","rawCompany":"eclaro","city":"Bothell","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-08-11T14:29:11.172Z","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":"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"},{"code":"334516","title":"Analytical Laboratory Instrument Manufacturing","slug":"analytical-laboratory-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Job Description: 100% Onsite position\nPURPOSE AND SCOPE OF POSITION:\nThe Equipment Validation Engineer supports the successful implementation of various process/lab\nequipment at multi-use sites through interaction with internal customers and external service\nproviders. The incumbent in this is tasked with commissioning and qualifying new equipment\nfacilities, utilities and maintaining equipment systems in a qualified / validated state according to\nestablished policies and procedures. The individual participates in projects and ongoing work\nactivities of low to moderate complexity. With minimum supervision and given general\ninstructions, this individual carries out routine tasks and functions, and uses basic analytical skills\nto recognize and solve common problems of limited scope. As a developing team player, the\nincumbent interacts with their immediate supervisor and personnel within their own work group\nto achieve team goals while building trust and collaborative relationships outside the immediate\norganization.\nREQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:\nKnowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer\nsystems 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\npharmaceutical industry.\nStrong written and verbal communication skills.\nExcellent interpersonal skills with experience dealing with a diverse workforce.\nStrong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize\nassigned tasks in a high paced environment and concurrently monitor tasks / assignmentswith others that may impact timely completion. Ability to effectively manage multiple tasksand activities simultaneously.\nHighly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and\nOutlook with extensive background in database systems. Innate ability to learn new software,such as corporate intranet and enterprise business.Education and Experience:\nBS in Engineering or Science related discipline required\nMinimum of 5 years’ experience performing/supporting activities in\na GMP environment.\nMinimum of 3 years’ experience in equipment, facility or utility\nqualificationDUTIES AND RESPONSIBILITIES:\n1) Maintains qualified equipment systems in compliance with policies, guidelines and procedures:\na. Develops qualification protocols, and associated reports while adhering to a change\nmanagement process.\nb. Supports the execution of equipment qualifications and validation protocols.\nc. Supervises vendors for qualification functions.\nd. Develops written procedures for calibration and preventive maintenance of equipment.\ne. Supports equipment qualification and validation activities.\nf. Develops validation/qualification deliverables such as Validation Plans, Requirements\nSpecifications, Traceability Matrices, Summary Reports, Change Controls.\n2) Manages projects of limited scope and complexity within their functional area:\na. Supports equipment implementation projects including scheduling, procurement, site prep,\ninstallation, qualification, and turn over to business area.\nb. Supports internal customer groups in the procurement, operation, calibration, and\npreventive maintenance of equipment to meet business needs in accordance with required\nschedules or dates.\nc. Completes all qualification and validation documentation with accuracy, completeness and\ncompliance to Client standards.\n3) Provides excellent customer service and support:\na. Regularly reviews, prioritizes and promptly responds to customer equipment qualification\nand support requests.\nb. Provides technical support and guidance on equipment qualification issues. Interfaces with\ncustomers to ensure all expectations are being met.\nc. Provides technical support and guidance on equipment and computer systems qualification\nand validations issues.\nd. Maintains a positive relationship with all team members and site customers while promoting\na positive team environment.\n4) Regulatory Responsibilities\na. Ensure equipment, facilities and programs are maintained in compliance.\nb. May be called upon as SME in both internal and regulatory audits.\nWORKING CONDITIONS (US Only):\nPhysical / Mental Demands:\nOccasional 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\npulling.Environmental Conditions:\nPrimarily office environment, but will be required to enter laboratory or GMP process areas\ndonning 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.\nJob Type: Contract\nPay: $60.00 - $75.00 per hour\nSchedule:\n8 hour shift\nAbility to commute/relocate:\nBothell, WA 98021: Reliably commute or planning to relocate before starting work (Required)\nExperience:\nEquipment Validation: 3 years (Required)\nComputer System Validation: 5 years (Required)\nCGMP: 6 years (Required)\nWork Location: In person","datePosted":"2026-08-11T14:29:11.172Z","dateModified":"2026-08-11T14:29:11.172Z","hiringOrganization":{"@type":"Organization","name":"Eclaro","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"4f12c020fe6b1f8c644fae86"},"url":"https://jobsearcher.com/jobs/4f12c020fe6b1f8c644fae86"}}