computer system validation csv engineer Jobs

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Computer System Validation (CSV) Engineer

Jobot

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Scottsdale, Arizona, USA

Full-time

Computer System Validation (CSV) Engineer with strong knowledge of FDA and cGMP regulations and documentation practices and 21 CFR Part 11. needed! (**Full relocation provided**) This Jobot Job is hosted by: Ryan Sullivan Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $130,000 - $145,000 per year A bit about us: We are a fast-growing, Medical Device Manufacturer in Scottsdale, AZ, passionate about improving the lives of patients suffering
Posted 1 day ago | Updated 3 hours ago

Computer System Validation CSV Engineer

VetForce Solutions

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Raritan, New Jersey, USA

Contract, Third Party

Role - Computer System Validation CSV Engineer Location - Raritan, NJ(Hybrid) Job Details: 7-10 years experience in Computer System Validation SAP ECC/S4, SolMan/ChaRM Change Control process Experienced in computer systems validation, GXP regulatory knowledge and good documentation methods and CSA approaches and risk-based validation. Knowledge in utilizing SDLC tools such as JIRA, qTest, X-ray, test automation tools and methods, Proficient knowledge on CFR Part 11 regulations and Quality Manag
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Posted 14 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 7 days ago | Updated 7 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Scottsdale, Arizona, USA

Full-time

Responsibilities: Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regulations, and cGMP regulations. Develop, review, and approve validation documents, including validation plans, test scripts, and final reports. Coordinate and conduct validation activities in accordance with project timelines and business objectives. Implement and manage document control processes and systems. Evaluate and recommend improvements to existing systems and processe
Posted 7 days ago | Updated 7 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 7 days ago | Updated 7 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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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 7 days ago | Updated 7 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 7 days ago | Updated 7 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 7 days ago | Updated 7 hours ago

Computer System Validation Specialist

SGS Consulting

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Remote

Contract

Job Title: Computer System Validation (CSV) Specialist Duration: 08 Months + (Possible Extension) Location: Wilmington, DE 19803 (Remote) Schedule: M-F: 08 AM 05 PM Kindly Do not apply if you are not or Permanent Resident of USA. Qualifications: The official position title is Computer System Validation (CSV) specialist to support the Newark manufacturing facility with validation of new and existing computerized systems.This role will primarily support the Newark manufacturing facility but may r
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Posted 28 days 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 7 days ago | Updated 7 hours ago

Corporate Automation Computer System Validation Engineer - API Drug Substance

Eli Lilly and Company

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Indianapolis, Indiana, USA

Full-time

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
Posted 9 days ago | Updated 7 hours ago

Benchling Technical Support Specialist (GxP / CSV Experience Preferred)

Infinite Computer Solutions (ICS)

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Remote

Third Party, Contract

Job Summary: We are seeking a skilled and proactive Technical Support Specialist with hands-on experience supporting Benchling, a leading cloud-based platform for life sciences R&D. The ideal candidate will have a strong background in providing technical application support within a regulated GxP environment, and exposure to Computer System Validation (CSV) is highly desirable. The role requires close collaboration with the client s IT and Quality teams to ensure consistent and compliant system
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Posted 20 days ago

Specialist Quality Management

Yoh - A Day & Zimmerman Company

•

Addison, Texas, USA

Contract

Are you a Quality Engineer with a passion for ensuring product integrity and regulatory compliance in a manufacturing environment? We re looking for a hands-on quality professional to lead root cause investigations, support validation efforts, and drive continuous improvement across our quality systems all within a highly regulated GMP setting. Must be local to the Dallas-Fort Worth area onsite required W2 only no C2C or third-party submissions accepted This is not a software QA position this ro
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Posted 7 days ago | Updated 4 hours ago

Validation Engineer - (CSV, CSQA)

Activesoft, Inc.

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Remote

Contract

Required Skills: IT Computer System Validation (CSV)Must have: Certified Software Quality Analyst (CSQA) certification.
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Posted 9 days ago | Updated 14 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 5 days ago | Updated 7 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 7 days ago | Updated 7 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 7 days ago | Updated 7 hours ago

Pharma Computer Systems Quality Assurance_ Long term contract || Remote

Accion Labs

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Remote

Third Party, Contract

This Computer Systems Quality Assurance role will be responsible for supporting the expansion of client s ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV) standards. Key Objectives/Deliverables: Maintain Inspectional Readiness Ensure supported systems are validatedEnsure all quality actions and commitments f
Easy Apply
Posted 14 days ago | Updated 9 days ago

Software Validation Quality Consultant | Contract, W2

Alpha Business Solutions LLC

•

Nutley, New Jersey, USA

Contract

Our direct client a large pharmaceutical company is seeking to hire a Software Validation Quality Consultant for 6 months plus contract to work hybrid from their Nutley, NJ Job Title: Software Validation Quality Consultant Duration: 6 months plus Location: Nutley, NJ | Hybrid - must be a local candidate willing to come on site at least 2 days a week, with one of them being Wednesday (more, if needed). Looking for someone who has done Validation in the clinical space. Google Cloud Platform and
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Posted 14 days ago | Updated 1 hour ago

CSV CONSULTANT :: Remote

TESTINGXPERTS, INC. DBA DAMCOSOFT

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New Jersey, USA

Third Party, Contract

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 13 days ago | Updated 1 day ago