computer system validation csv engineer Jobs

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CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

•

Kansas City, Missouri, USA

Full-time

Responsibilities: Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports) Experience in validating GMP Lab systems and Equipment. Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project. Identify and escalate, as necessary project risks and issues to the CSVC Manager. Engage
Posted 26 days ago | Updated 6 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 28 days ago | Updated 6 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

San Juan, San Juan, Puerto Rico

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments. Test planning and strategy. creation and execution of test protocols, scripts and reports.
Posted 28 days ago | Updated 6 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Cincinnati, Ohio, USA

Full-time

Responsibilities: Develop Project Plans for the qualification of the Drug Substance Manufacturing (DSM), Drug Product (DP). Finished Goods Manufacturing (FGM) Manufacturing, and IT Computerized Systems. Assist in the generation and development of documents, processes, and procedures of the Computer Systems Validation (CSV) program. Generate and review Manufacturing and IT Computerized Systems lifecycle documentation including risk and impact assessments, user requirement specifications, function
Posted 28 days ago | Updated 6 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Libertyville, Illinois, USA

Full-time

Responsibilities: The Manufacturing IT Systems Quality & Compliance Specialist- Cell Therapy Manufacturing Systems supports the successful operation of manufacturing and business functions at Libertyville site through interaction with internal team members, peer and higher-level customers as well as external service providers. The individual is responsible for the development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work a
Posted 28 days ago | Updated 6 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 28 days ago | Updated 6 hours ago

CSV Lead Instrument Software Validation

NTT DATA Americas, Inc

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Remote or Almont, Colorado, USA

Contract

CSV Lead Instrument Software Validation - 25-05061 100% Remote | CAD or USA 6+ Mths Duration W2/T4 or C2CNTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a CSV Lead Instrument Software Validation to join their team in Calgary, Ontario (CA-ON), Canada (CA).Job Description: Experience Level: 5-7 Years Job Descri
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Posted 8 days ago | Updated 1 hour ago

Lead Engineer MES OpCenter

New York Technology Partners

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Remote

Contract

Job Title: Lead Engineer MES OpCenter Location: 100% Remote Experience: 12+ Years JD: Lead Engineer MES OpCenter The Lead Engineer will lead a team of technical resources to design, develop, configure and test MES (Manufacturing Execution Systems) solutions. They will be directly responsibility for leading resources contracted via a third-party and through other J&J organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. The Lead Engineer will b
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Posted 5 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 28 days ago | Updated 6 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

New Brunswick, New Jersey, USA

Full-time

Responsibilities: Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in establishing standard quality and validation pract
Posted 28 days ago | Updated 6 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

•

Lawrence Township, New Jersey, USA

Full-time

Roles & Responsibilities: 8-10+ Years of Overall IT Experience Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix. Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review. Participate in
Posted 28 days ago | Updated 6 hours ago

CSV Lead Instrument Software Validation

VDart, Inc.

•

CA

Third Party, Contract

Role: CSV Lead Instrument Software Validation Location: Calgary, NS (Remote) Type: Contract Job Description: We are seeking an experienced Instrument Software Validation Project CSV Lead to join our team. The ideal candidate will have a strong background in European regulations compliance, GxP/Validation expertise, and business analysis. This role is critical for ensuring the successful validation of our instrument software in compliance with regulatory standards. Key Responsibilities: Lead an
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Posted 1 day ago | Updated 8 hours ago

Clinical QA Lead

Bahwan CyberTek Inc.

•

Boston, Massachusetts, USA

Contract, Third Party

Title : Clinical QA Lead Location: Boston, MA (Hybrid) Duration : Long term Description: Minimum of 8 years of software quality testing experience and 12+ years IT/Industry experience. 5+ years of experience in Computer Systems Validation (CSV) in the context of Good Clinical/Manufacturing Practices (GxP) is preferred. Experience with software application test planning and functional testing, performance testing, developer management, and defect management using Application lifecycle management
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Posted 9 hours ago

Project Manager with IQMS or DELMIAworks Experience - M

Next Step Systems

•

Boyertown, Pennsylvania, USA

Full-time

Project Manager with IQMS or DELMIAworks Experience We a seeking a Project Manager for a great opportunity in Boyertown, PA. The Project Manager in this position is to report to and receive directions from the Director, Information Technology. The role is based in Boyertown, PA, and requires 3 days Onsite (Tuesday, Wednesday, Thursday). Willingness and ability to travel up to 25% (1-2 times every 2 months). Project Manager Responsibilities: - The Project Manager will manage the daily operatio
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Posted 2 days ago | Updated 1 day ago

Data Management Specialist Aveva PI

Multivision Inc-IL

•

Indianapolis, Indiana, USA

Contract, Third Party

Job Title: Data Management Specialist Aveva PI Location: Indiana, IN (Hybrid) Role: Contract Duration: 12 Months Key Responsibilities: Collaborate with site teams, Data Integrity champions, Engineering Tech Centres, and Technical Services to define data architectures and models Participate in the overall design of scalable and compliant data architecture Develop specifications and scope documents for data management initiatives Lead the execution and delivery of data management projects Oversee
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Posted 6 days ago

MES Engineer

LanceSoft Inc.

•

Summit, New Jersey, USA

Full-time, Third Party

Role: MES Engineer Location: Summit, NJ 07901 Duration: 06 months Must be onsite 50% of the time at either Summit West, Giralda Farms, Princeton Pike, Lawrenceville, or New Brunswick. Must Have List 4+ years of Computer System Validation (CSV) experience in regulated pharmaceutical and biotech environments, with strong knowledge of GAMP 5, 21 CFR Part 11, and Computer Software Assurance (CSA) principles.3+ years of hands-on MES experience with Emerson Syncade, including recipe validation, EBR te
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Posted 13 days ago

CSV CONSULTANT :: Remote

TESTINGXPERTS, INC. DBA DAMCOSOFT

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New Jersey, USA

Contract, Third Party

Mandatory Skills CSV, Compliance and Assurance services, LIFE-SCIENCES (GXP FDA CSV IQ/OQ/PQ), Veeva, Argus, Defect Tracking Tools_JIRA Primary Skill- Computer System Validation, Computed system assurance, GAMP, GxP risk assessments, Change Management Secondary Skill- JIRA Veeva Argus Agile and Waterfall methodology Jo Description: Strong experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems P
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Posted 34 days ago | Updated 23 hours ago

Validation Engineer

LanceSoft Inc.

•

Portsmouth, New Hampshire, USA

Contract

Title: CSV Analytical and Enterprise Validation Specialist Location: Portsmouth, NH 03801 Duration: 12 Months Description: CSV, Analytical and Enterprise Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, Administration of systems and applications, and decommissioning activities as appropriate. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Valid
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Posted 14 days ago

LABWARE Resource / Consultant

Intone Networks Inc.

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Remote or US

Full-time, Contract, Third Party

LABWARE Resource / Consultant 100% Remote Long Term Key Responsibilities: Design, configure, and program within LabWare LIMS Version 8 and Biovia OneLab to meet business and laboratory requirements. Develop and maintain Crystal Reports for operational and analytical reporting. Implement and manage laboratory instrument and external system integrations using both file-based and API-based methods. Collaborate with cross-functional teams to analyze requirements, document functional specificat
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Posted 15 days ago | Updated 10 hours ago

IT Project Manager (RPA, AI)

Recruitment.ai

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Chadds Ford, Pennsylvania, USA

Contract

Job Summary: The Project Manager (RPA/AI) is responsible for managing the Robotic Process Automation and AI/ML portfolio. The role collaborates with the cross-functional business areas including Clinical, Discovery, Finance, TechOps, and Development to understand business processes, gather requirements, evaluate, prioritize, and implement RPA robots and AI/ML-based solutions. The role liaises with internal IT, onshore and offshore RPA consultants and developers to create RPA bots and AI/ML-based
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Posted 15 days ago