computer system validation csv manager 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 1 day ago | Updated 7 hours 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. 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
Posted 20 hours ago | Updated 9 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 60+ days ago | Updated 9 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 9 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 60+ days ago | Updated 9 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 9 hours ago

Need - Computer Software Validation (CSV) Engineer

ASCII Group LLC

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Santa Clara, California, USA

Contract, Third Party

Hi, The following requirement is open with our client. Title : Computer Software Validation (CSV) Engineer Location : Santa Clara, CA (ONSITE) Duration : 12+ Months Relevant Experience (in Yrs.) : 8+ Job Description: Minimum of 4-5 years of experience in software quality assurance or software validation, preferably within the medical device industry.Strong understanding of quality standards and regulatory requirements (e.g., FDA 21 c, ISO 13485, IEC 62304).Experience with non-product software v
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Posted 3 days ago

Validation Engineer

Source Code Technologies LLC

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Sunnyvale, California, USA

Contract

Role name: Validation Engineer Branch | City | Location: Sunnyvale/ Santa Clara, CA Duration: 6 Months Keywords: Key Words to search in Resume Computer System Validation, 21 CFR Part 11, GxP, FDA, 21 CFR Part 11, ISO 13485, IEC 62304 Role 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 sof
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Posted 2 days ago

Validation Specialist CSV & OT Systems

Galent

•

Muskegon, Michigan, USA

Contract, Third Party

We are seeking a skilled Validation Specialist with hands-on experience in Computer System Validation (CSV) and Operational Technology (OT) systems. The successful candidate will support validation activities across control systems such as DeltaV, ABB DCS, Historian, MES, and other regulated automation platforms. You will work under the direction of the Validation Lead, Automation Lead, and Project Manager, performing validation tasks and ensuring compliance with GxP, FDA, and cGMP guidelines. K
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Posted 2 days ago

Project Manager with IQMS or DELMIAworks Experience - G

Next Step Systems

•

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 8 days ago | Updated 19 hours ago

CSV Engineer

Shrive Technologies LLC

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New Jersey, USA

Contract, Third Party

Job Details: 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 ServiceNOW, 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 Application of FDA guidance's and industry standards (
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Posted 11 hours ago

Sr. Cleaning Validation Engineer

VetForce Solutions

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Seattle, Washington, USA

Contract

Sr. Cleaning Validation Engineer Onsite in Seattle, WA 6 month contract to start with likely extensions Musts- 8+ years of experience in cleaning validation within GMP/CDMO environments Strong knowledge of cleaning processes, facility/utilities validation, and regulatory requirements Experience with computer system validation (CSV) preferred Demonstrated ability to write, review, and execute validation documentation
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Posted 1 day ago

Automation Controls Engineer (2ndShift)

Bytecubit Technologies

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Indianapolis, Indiana, USA

Contract

Job Title: Automation Controls Engineer (2nd Shift)Location: Indianapolis, INDuration: 6 monthsPay Rate: $45/hr-$55/hr (depending on experience) Job Description: This role will be responsible for supporting the design, installation, and validation for the sterile purification and recycling isolators into commercial production. Bachelor s degree in engineering, Computer Science, Automation, or related field with 7+ years of relevant engineering experience in the Pharmaceutical or Chemical indust
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Posted 23 days ago

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

Sovereign Technologies

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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 1 day 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 16 days ago | Updated 8 hours ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

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San Francisco, California, USA

Full-time

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. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 60+ days ago | Updated 9 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and
Posted 48 days ago | Updated 8 hours ago

Medical Device Engineer

Katalyst Healthcares and Lifesciences

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North Chicago, Illinois, 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 20 hours ago | Updated 8 hours ago

Medical Device & Regulations 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 applicabil
Posted 4 days ago | Updated 8 hours ago

CSV Engineer

Katalyst Healthcares and Lifesciences

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Nutley, New Jersey, USA

Full-time

Job Description: Looking for someone who has done Validation.Google Cloud Platform and CSV. Must understand the business of clinical. We are seeking a versatile professional with the ability to review documents meticulously and support the creation of validation deliverables as needed. The ideal candidate will thrive in a challenging environment and possess the skills to effectively communicate the importance of validation processes to stakeholders outside the validation team. Responsibilities:
Posted 60+ days ago | Updated 9 hours ago