computer system validation csv engineer Jobs

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Computer System Validation (CSV) Engineer

VDart, Inc.

•

Muskegon, Michigan, USA

Full-time, Part-time, Contract, Third Party

Job Title: Computer System Validation (CSV) Engineer Location: Muskegon, MI (Onsite) Job Type: Contract 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 wit
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Posted 3 days ago | Updated 1 day ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author 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
Posted 24 days ago | Updated 6 hours ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

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Kansas City, Missouri, USA

Full-time

Roles & 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 Manage
Posted 60+ days ago | Updated 6 hours ago

Lead/Sr Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Muskegon, Michigan, USA

Full-time

Responsibilities: The CSV Lead manages quality control checks on engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols. The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams
Posted 2 days ago | Updated 6 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 6 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 6 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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 60+ 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 60+ days ago | Updated 6 hours ago

Validation Engineer/CSV Engineer

Katalyst Healthcares and Lifesciences

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Walnut Creek, California, USA

Full-time

Responsibilities: 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 applicabi
Posted 3 days ago | Updated 6 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati
Posted 60+ days ago | Updated 6 hours ago

Computer Systems Validation Engineer

Katalyst Healthcares and Lifesciences

•

Bethlehem, Pennsylvania, USA

Full-time

Job Description: We're seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regulated environments and hands-on experience with modern lab software and instrumentation. This is a short-term contract assignment running through September and requires individuals to work onsite. Responsibilities
Posted 8 days ago | Updated 6 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 6 hours ago

Sr. CSV Validation Engineer

Katalyst Healthcares and Lifesciences

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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 60+ days ago | Updated 6 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

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Santa Clara, California, USA

Full-time

Responsibilities: 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 applicabi
Posted 16 days ago | Updated 6 hours ago

Senior Pharma GxP Project Manager with a strong background in SAP S/4 HANA validation

Pioneer Corporate Services Inc

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Foster City, California, USA

Third Party, Contract

Job Title: Senior Pharma GxP Project ManagerLocation: Hybrid Foster City, CA (Locals or nearby states preferred)Duration: 12 Months Job Description:We are seeking a Senior GxP Project Manager with a strong background in SAP S/4 HANA validation and Life Sciences industries. The role demands excellent stakeholder and change management skills, hands-on validation expertise, and solid project leadership. Must-Have Skills: 15 20 years of overall experience 8+ years in Computer System Validation (CSV)
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Posted 11 days ago | Updated 11 days ago

Project Manager with IQMS or DELMIAworks Experience - G

Next Step Systems

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Boyertown, Pennsylvania, USA

Full-time

Project Manager with IQMS or DELMIAworks Experience, Boyertown, PA 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
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Posted 4 days ago | Updated 2 days ago

Oracle WAMS/CCB Functional Resource

Catapult Solutions Group

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Remote

Contract

Oracle WAMS/CCB Technical/Functional ResourceLocation: Remote (some travel required) Contract No C2C or Sponsorship available About Our ClientOur client is a leading Fortune 500 technology, engineering, and science solutions company with over 50 years of innovation and excellence. They deliver advanced technology solutions across defense, intelligence, civil, and health markets, serving government and commercial customers worldwide. Operating from offices across the United States and internation
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Posted 2 days ago

IQ/OQ/PQ Validation Engineer with Medical (W2)

Sovereign Technologies

•

Irvine, California, USA

Full-time

Title: Sr. Validation engineer with Medical Device Candidates Location: Onsite in Irvine, CA Duration: 2+ years 1) Word copy of resume 2) 2-3 professional references THIS IS NOT A SOFTWARE POSITION Looking for hands on IQ/OQ/PQ Validation in Medical Device Candidates MUST HAVE Bachelor of Science in Engineering or a related subject with 4+ years of experience in validation GMPs.Good understanding of engineering and machine tool fundamentals.Written and owned the validation processSME on IQ/OQ/PQ
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Posted 17 days ago | Updated 11 days ago

Senior Staff, Software Quality Assurance Engineer

Stryker

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Portage, Michigan, USA

Full-time

Work Flexibility: Hybrid Senior Staff, Software Quality Assurance Engineer Stryker is seeking a Senior Staff Software Quality Assurance Engineer to support our Digital Robotics and Enabling Technologies business by driving quality processes. In this role, you will partner with R&D software development teams to guide them through internal quality system processes and ensure compliance with regulatory standards, including FDA, HIPAA, ISO, and SOC 2. Work Flexibility: Hybrid: Candidates must resi
Posted 15 days ago | Updated 6 hours ago

SUD Validation Engineer

Thermo Fisher Scientific

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Logan, Utah, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 33 days ago | Updated 6 hours ago