CSV Engineer jobs

Summit, New Jersey

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Today

Job Summary (List Format): - Minimum 5 years of experience in the life sciences industry - Strong knowledge of Computerized Systems Validation (CSV) - Experience drafting validation lifecycle documents (Validation Plans, IQ/OQ/PQ protocols, RTM, VSR) - Proficient in deviation and change management processes - Familiarity with project management principles - Solid understanding of 21 CFR Part 11 regulations - Experience validating laboratory instruments - Skilled in IT collaboration and tr

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Third Party, Contract

Hiring for Technical Writer / Document Controller (CSV AND Kneat Focus) || Indianapolis, IN

Indianapolis, Indiana

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20d ago

Title: Technical Writer / Document Controller (CSV Focus) Location: Indiana, IN (Hybrid) On-site Requirement: As required based on project phase Purpose of the Role: The Technical Writer / Document Controller will support documentation and CSV deliverables across multiple projects within the client s Foundry Program. Key Responsibilities: Support validation activities as per the approved Validation Plan and CSV documentation standards. Assist in drafting, updating, and maintaining validation d

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Third Party, Contract

$60 - $70

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

CSV Engineer

Indianapolis, Indiana

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Today

Responsibilities: Interface with client Subject Matter Experts, Site and Area Management, Quality Assurance, and other stakeholders for validation planning. Guide the creation and updates of project validation planning deliverables such as Validation, Security, and Test Plans. Support execution of validation activities in alignment with the approved Validation Plan and CSV documentation standards. ssist Project CSV Leads in generating/editing CSV documents and electronic testing templates. Recom

Full-time

CSV Engineer

Veterans Administration, New York

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Today

Responsibilities: Validation & Documentation. uthor, review, and execute validation documentation including User Requirement Specifications (URS), Functional Specifications, Design Qualification (DQ), FAT, SAT, IQ, OQ, and PQ. Manage validation lifecycle documentation using Kneat. Perform risk assessments (FMEA, GxP impact assessments, traceability matrices.) utomation Systems (DeltaV & others.) Support automation projects involving DeltaV Distributed Control Systems (DCS), PLCs, and SCADA syste

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

CSV Engineer

San Francisco, California

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Today

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Roles & Responsibilities: 10Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnol

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

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

CSV Support Engineer

Greenfield, Indiana

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Today

Responsibilities: Empower Administration & Support. Manage user accounts, access rights, roles, and privileges in Empower. Perform system configuration, project management, and template/report customization. Provide day-to-day L2/L3 support for Empower users across QC/analytical labs. Instrument Integration & Troubleshooting. Integrate lab instruments (HPLC, UPLC, Dissolution, UV, etc.) with Empower. Troubleshoot connectivity, data acquisition, and communication issues between instruments and C

Full-time

CSV Engineer

Bellevue, Washington

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Today

Job Description: Experience Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes Follow SOPs and industry best practices Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar. Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development

Full-time

Senior Principal Engineer - Automation Engineering - CSV

Lebanon, Indiana

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Today

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined

Full-time

USD 64,500.00 per year

Computer system validation Engineer (CSV)

Bridgewater, New Jersey

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Today

Roles & Responsibilities: Experience designing, implementing, and operating IT risk management, IT quality and IT compliance activities in a life sciences organization, with particular focus on GxP, IT internal controls, SDLC management. Experience designing, implementing, and navigating waterfall and agile SDLC (System Development Life Cycle). Experience in SAP/ERP Validation and test management. Experience leading IT risk, IT quality and IT compliance transformational programs. Experience in e

Full-time

Validation Engineer/CSV Engineer

Walnut Creek, California

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Today

Job Description: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicability

Full-time

CSV Engineer

New Jersey

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Today

Roles & Responsibilities: We are now looking for a resource on the validation side of things going on here. Depending on the resource, we're looking for someone with (LabVantage) LIMS and quality systems validation experience, and/or general more broad Pharma/Biotech CSV experience that could back-fill as staff augmentation. Engagement would be (at least) through the end of the year. Potential in-scope activities. i. CSV/Lab Systems Qualification document/deliverable authoring. ii. Test script/p

Full-time

CSV Engineer

Raritan, New Jersey

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Today

Roles & Responsibilities: 7-10 years' experience in Computer System Validation of SAAS systems, and Cloud systems. Must have experience in Agile methodology and handled multiple releases in parallel. Has working experience in any one or two of the following domains Tool validation like Service Now, Automation tools, JIRA. Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC. pplication of FDA guidance's and ind

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

Sr. Validation Engineer (CSV)

Muskegon, Michigan

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Today

Roles & Responsibilities: The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager. Perform initial CSV at client site for systems including DeltaV, Historian, MES, ABB as well as other DCS and OT systems. They will review and approve risk assessment link to CSV of systems. Collaborate with the other departments, within their respective areas of responsibility for Change Management a

Full-time

CSV Engineer

Santa Clara, California

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Today

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. This role ensures the systems are compliant, reliable, and fit for intended use, supporting quality and regulatory requirements across the organization. Responsibilities: Develop and execute Computer System Validation (CSV) de

Full-time

Sr. CSV Engineer

Philadelphia, Pennsylvania

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Today

Roles & Responsibilities: Lab CSV consultant needed. Working on standard lab equipment systems, temp monitoring systems will be the first but will also include HPLC, and various other lab equipment. helping define a program and plan for validation. Work cross functionally with decision manager for writing SOPS and procedures, defining how to contribute to execution. There is a current team in place but they are scientists and not CSV experts so this person should really be 10+ years of expe

Full-time

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CSV Engineer jobs