{"schemaVersion":"jobsearcher.job.v1","id":"180578accdfbb3ea422ccfda","url":"https://jobsearcher.com/jobs/180578accdfbb3ea422ccfda","canonicalUrl":"https://jobsearcher.com/jobs/180578accdfbb3ea422ccfda","title":"Senior Quality Engineer, Computer System Validation (CSV)","description":"The Sr Quality Engineer, Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems and any associated GMP equipment ensuring they are implemented, maintained, and retired in accordance with global regulatory requirements, industry standards, and internal procedures.\n\nPrimary Responsibilities\nIndividual Responsibilities\nGxP Systems & Applications\n\nCollaborate with IT and GxP system business owners to ensure internal CSV processes and procedures are aligned to GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9 (risk management), ICH Q10 (PQS), and FDA’s Computer Software Assurance (CSA) guidance.\n\nServe as a team member to provide qualification expertise to CMC, Manufacturing Operations, Facilities, Quality Control and Engineering departments.\n\nProvide QA oversight for new system implementations, upgrades, integrations, cloud/SaaS solutions, and decommissioning activities.\n\nExperience validating GxP computerized systems, associated equipment (hardware) and digital platforms across laboratory, manufacturing, quality, ERP, or cloud-based environments\n\nApprove validation deliverables (validation/assurance planning, testing strategy, traceability, UAT, periodic review, and retirement/archival plan, risk assessments, protocols, reports).\n\nEnsure validated systems remain in a controlled state through change management, periodic review, requalification, deviation management, and CAPA.\n\nServe as QA reviewer/approver of deviations, CAPAs, change controls and effectiveness checks.\n\nCollaborate with customers and internal stakeholders to define validation strategies, risk-based approaches, and compliant delivery models aligned with GxP expectations\n\nReview/approve comprehensive validation documentation, including validation plans, user and functional requirements, risk assessments, test scripts, and summary reports.\n\nCoordinate with vendors for maintenance, upgrades, and issue resolutions to minimize downtime.\n\nPrimary Skills and Knowledge\n\nMust have previous experience in Quality Assurance or Quality Engineering\n\nMust have previous experience with GAMP5 system validation and validation of associated equipment.\n\nApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\nStrong experience with regulated laboratory and/or manufacturing systems\n\nUnderstanding of access control, security principles, and audit trail requirements in regulated environments.\n\nAbility to manage GxP system lifecycle activities including change control, deviations, CAPAs, and periodic reviews.\n\nStrong documentation skills with experience authoring and maintaining validation and technical support documentation.\n\nEffective communication and collaboration skills, with the ability to interface between technical teams, vendors, and business stakeholders.\n\nStrong analytical and problem-solving skills with the ability to troubleshoot complex system issues in a timely manner.\n\nHigh attention to detail and commitment to data integrity.\n\nProven ability to lead medium-to-large projects, drive planning/controlling, and utilize tools like RCA, FMEA, and VSM.\n\nExperience supporting audits, inspections, supplier assessments, CAPA activities, data integrity initiatives, or compliance remediation programs is considered an advantage.\n\nLevel of Education Required\n\nBachelor’s degree (Scientific or Engineering discipline, or other technical disciplines); master's degree a plus\n\nNumber of Years of Experience in the Function and in the Industry\n\nMinimum of 8+ years experience in the pharmaceutical or biotechnology industry\n\nMust have 3+ years’ experience in GxP computerized system validation and associated equipment within the pharmaceutical, biotech, or medical device industry.\n\nSalary Range\n$142,140 - $179,220 USD\n\nEyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.\n\nEyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.\n\n#J-18808-Ljbffr","company":"Initial Therapeutics","rawCompany":"initial therapeutics","city":"Northbridge","state":"MA","isRemote":false,"isActive":true,"createdAt":"2026-06-29T03:23:01.378Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"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":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Senior Quality Engineer, Computer System Validation (CSV)","description":"The Sr Quality Engineer, Computer System Validation (CSV) is responsible for QA oversight of the validation and compliance of GxP-regulated computerized systems and any associated GMP equipment ensuring they are implemented, maintained, and retired in accordance with global regulatory requirements, industry standards, and internal procedures.\n\nPrimary Responsibilities\nIndividual Responsibilities\nGxP Systems & Applications\n\nCollaborate with IT and GxP system business owners to ensure internal CSV processes and procedures are aligned to GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9 (risk management), ICH Q10 (PQS), and FDA’s Computer Software Assurance (CSA) guidance.\n\nServe as a team member to provide qualification expertise to CMC, Manufacturing Operations, Facilities, Quality Control and Engineering departments.\n\nProvide QA oversight for new system implementations, upgrades, integrations, cloud/SaaS solutions, and decommissioning activities.\n\nExperience validating GxP computerized systems, associated equipment (hardware) and digital platforms across laboratory, manufacturing, quality, ERP, or cloud-based environments\n\nApprove validation deliverables (validation/assurance planning, testing strategy, traceability, UAT, periodic review, and retirement/archival plan, risk assessments, protocols, reports).\n\nEnsure validated systems remain in a controlled state through change management, periodic review, requalification, deviation management, and CAPA.\n\nServe as QA reviewer/approver of deviations, CAPAs, change controls and effectiveness checks.\n\nCollaborate with customers and internal stakeholders to define validation strategies, risk-based approaches, and compliant delivery models aligned with GxP expectations\n\nReview/approve comprehensive validation documentation, including validation plans, user and functional requirements, risk assessments, test scripts, and summary reports.\n\nCoordinate with vendors for maintenance, upgrades, and issue resolutions to minimize downtime.\n\nPrimary Skills and Knowledge\n\nMust have previous experience in Quality Assurance or Quality Engineering\n\nMust have previous experience with GAMP5 system validation and validation of associated equipment.\n\nApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\nStrong experience with regulated laboratory and/or manufacturing systems\n\nUnderstanding of access control, security principles, and audit trail requirements in regulated environments.\n\nAbility to manage GxP system lifecycle activities including change control, deviations, CAPAs, and periodic reviews.\n\nStrong documentation skills with experience authoring and maintaining validation and technical support documentation.\n\nEffective communication and collaboration skills, with the ability to interface between technical teams, vendors, and business stakeholders.\n\nStrong analytical and problem-solving skills with the ability to troubleshoot complex system issues in a timely manner.\n\nHigh attention to detail and commitment to data integrity.\n\nProven ability to lead medium-to-large projects, drive planning/controlling, and utilize tools like RCA, FMEA, and VSM.\n\nExperience supporting audits, inspections, supplier assessments, CAPA activities, data integrity initiatives, or compliance remediation programs is considered an advantage.\n\nLevel of Education Required\n\nBachelor’s degree (Scientific or Engineering discipline, or other technical disciplines); master's degree a plus\n\nNumber of Years of Experience in the Function and in the Industry\n\nMinimum of 8+ years experience in the pharmaceutical or biotechnology industry\n\nMust have 3+ years’ experience in GxP computerized system validation and associated equipment within the pharmaceutical, biotech, or medical device industry.\n\nSalary Range\n$142,140 - $179,220 USD\n\nEyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint’s compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity.\n\nEyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.\n\n#J-18808-Ljbffr","datePosted":"2026-06-29T03:23:01.378Z","dateModified":"2026-06-29T03:23:01.378Z","hiringOrganization":{"@type":"Organization","name":"Initial Therapeutics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Northbridge","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"180578accdfbb3ea422ccfda"},"url":"https://jobsearcher.com/jobs/180578accdfbb3ea422ccfda"}}