computer system validation csv manager Jobs

Refine Results
1 - 20 of 76 Jobs

Quality Assurance Manager

tCognition, Inc

•

Remote

Full-time

JD for Quality Assurance Manager
Easy Apply
Posted 4 days 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 34 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 34 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 34 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 34 days ago | Updated 6 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

•

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 34 days ago | Updated 6 hours ago

Lead Engineer MES OpCenter

New York Technology Partners

•

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
Easy Apply
Posted 6 days 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
Easy Apply
Posted 6 days 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
Easy Apply
Posted 12 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
Easy Apply
Posted 19 days ago

CSV CONSULTANT :: Remote

TESTINGXPERTS, INC. DBA DAMCOSOFT

•

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
Easy Apply
Posted 40 days ago | Updated 14 hours ago

LABWARE Resource / Consultant

Intone Networks Inc.

•

Remote or US

Full-time, Third Party, Contract

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
Easy Apply
Posted 21 days ago | Updated 10 hours ago

IT Project Manager (RPA, AI)

Recruitment.ai

•

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
Easy Apply
Posted 21 days ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

•

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 34 days ago | Updated 6 hours ago

Validation Support Engineer

Katalyst Healthcares and Lifesciences

•

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 18 days ago | Updated 6 hours ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

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 32 days ago | Updated 6 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
Easy Apply
Posted 20 days ago

CSV Engineer

Katalyst Healthcares and Lifesciences

•

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 34 days ago | Updated 6 hours ago

CSV LEAD

HCL America Inc.

•

King of Prussia, Pennsylvania, USA

Full-time

We are HCLTech, one of the fastest-growing large tech companies in the world and home to 219,000 people across 60 countries, supercharging progress through industry-leading capabilities centered around Digital, Engineering and Cloud. ( ) The driving force behind that work, our people, are diverse, creative, and passionate, raising the bar for excellence on a regular basis. We, in turn, work hard to bring out the best in them as we strive to help them find their spark and become the best version
Easy Apply
Posted 20 days ago

IT infrastructure CSV Consultant

Katalyst Healthcares and Lifesciences

•

Cranbury, New Jersey, USA

Full-time

Responsibilities: We are seeking a Validation & IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. IT Infrastructure guy who has worked in the Pharma industry, having 21 CFR part 11 exp. Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment. Manage system configurations, troubleshooting
Posted 34 days ago | Updated 6 hours ago