computer system validation csv engineer Jobs

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Need CSV Computer System Validation

iTvorks Inc

•

Pittsburgh, Pennsylvania, USA

Contract

Need CSV Computer System Validation
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Posted 6 days ago

CSV Engineer (Computer System Validation)

Katalyst Healthcares and Lifesciences

•

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 49 days ago | Updated 10 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 49 days ago | Updated 10 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 49 days ago | Updated 10 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 49 days ago | Updated 10 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 49 days ago | Updated 10 hours ago

Quality Assurance Manager

tCognition, Inc

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Remote

Full-time

JD for Quality Assurance Manager
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Posted 19 days 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 49 days ago | Updated 10 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 49 days ago | Updated 10 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 49 days ago | Updated 10 hours ago

Clinical QA Lead

Bahwan CyberTek Inc.

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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 21 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
Easy Apply
Posted 1 day ago | Updated 19 hours ago

Validation Engineer

Primary Talent Partners

•

East Syracuse, New York, USA

Contract

Primary Talent Partners has an open 12 month W2 contract with a large biologics client of ours in the Syracuse, NY area.Pay Range: $52.00 to $57.00 per hour (No PTO, benefits, etc but self funded ACA-compliant healthcare plan available to opt-in to) Job ResponsibilitiesResponsible for preparing computer system validation documents to comply with local and global regulatory requirements, and internal company standards. Ensure IT personnel complete QMS actions and routine system compliance activ
Easy Apply
Posted 6 days ago | Updated 4 hours 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 27 days ago

Automation Controls Engineer (2ndShift)

Bytecubit Technologies

•

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 8 days ago

Validation Lead

Cynet Systems

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King of Prussia, Pennsylvania, USA

Contract

Job Description: Pay Range: $50hr - $55hr 10+ years' Experience in Validating systems and Experienced in CSV activities in GxP related applications like SAP Systems, Product Serialization systems, MES systems Perform review for GxP systems to ensure compliance with regulatory requirements Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology-based software development Compliance and h
Easy Apply
Posted 1 day ago | Updated moments ago

SUD Validation Engineer

Thermo Fisher Scientific

•

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 1 day ago | Updated 10 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 49 days ago | Updated 10 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 33 days ago | Updated 10 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 49 days ago | Updated 10 hours ago