CSV Engineer jobs in Massachusetts

Cambridge, Massachusetts

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Today

Roles & Responsibilities: - Build and maintain ETL pipelines, metadata, mappings, and automated data quality/validation rules. Configure elluminate study modules (Mapper, Data Central, CTOA, Sample Management, Protocol Deviations) and translate requirements into specifications. Contribute in testing/validation (IQ/OQ/PQ, UAT) efforts, manage audit trails, and resolve issues with vendors and study teams. Develop dashboards/analytics across elluminate modules and monitor system performance, inte

Full-time

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Senior CSV Engineer

Remote or Massachusetts

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Today

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

Computer System Validation - CSV Engineer

Remote or New Jersey

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Today

Roles & Responsibilities: Minimum 8+ years of relevant experience; can work independently and guide/mentor Junior resources. Experience in the Pharmaceutical, biotechnology, or medical device industry with System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation. Knowledge of FDA guidance's and industry standards (i.e., GAMP) Experience in writing and executing documen

Full-time

IT CSV Engineer

Boston, Massachusetts

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Today

Responsibilities: Works with the project team to author qualification deliverables such as Infrastructure/Network specifications, Qualification Protocols, Test Cases, Risk Assessments, and Summary Reports. Develop system development life cycle documents related to site infrastructure. This includes system specification documents, qualification plans and test protocols, and procedures. Coordinate qualification activities, propose and implement qualification strategies. Support the operational tea

Full-time

IT CSV & CQV Validation Lead

Boston, Massachusetts

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Today

Responsibilities: Documentation & Deliverables: Develop and author comprehensive validation and quality documentation, including protocols, reports, risk assessments, SOPs, and other project-related materials. Ensure all documentation complies with applicable regulatory standards such as FDA, EMA, GxP, and other relevant guidelines. Review and approve validation documents to confirm alignment with both project objectives and regulatory requirements. Project Management: Lead and oversee multiple

Full-time

Computer System Validation (CSV) Engineer

Remote or Massachusetts

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Today

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree

Full-time

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CSV Engineer jobs in Massachusetts, USA