Responsibilities: Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations). Bachelor's degree or equivalent experience in computer science, information technology, or a related field. High degree of proficiency in Microsoft Office Suite and Smartsheet. Detail-oriented with a strong analytical mindset and problem-solving capabilities. Excellent project

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the

Roles & Responsibilities: Bachelor's degree in engineering, Life Sciences, Computer Science, or a related field. Minimum of 3-5 years of experience in validation within the pharmaceutical, biotech, or medical device industries. Develop and execute validation protocols (IQ, OQ, PQ) for the migration of lab instruments from Windows 7 to Windows 10. Conduct thorough assessments of existing lab instruments to identify compatibility issues and ensure all instruments are supported on Windows 10. Ensur

Job Title: Validation Engineer Job Location: Middletown, NJ (Remote is also fine) Job Duration:12 months Job Description: This position allows you to assist customers in optimally crafting, deploying, operating, and continuously improving cost-effective solutions based on a Service-Aware Operating System (SAOS) based Routing & Switching portfolio (RSP) and its associated network management platform. This is an on-customer premise technical role with a focus on facilitating customers to understan

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

Position: RTL Validation Engineer Location: Dallas, TX ( Remote) Duration: 6 months Visa Preference: GC s, EAD s, L2 EAD s RTL Validation, working knowledge of PCIE/CXL protocols. Familiarity with simulation technologies.Exceptional analytical skills and problem solving skills.Experience in crafting testbenches, methodologies for large and complex chips.Deep understanding of verification concepts.Proficiency with at least one of these - C++, Object Oriented Programming, UVM, System Verilog.Fam

Regeneron is currently looking for a Principal/ Staff Process Controls & Validation Engineer for the Labeled Drug Product fill/finish manufacturing processes. This is Monday-Friday, 8am-4:30pm schedule. Process Sciences is a technical services department that deals with a range of scientific, technical, engineering, and mathematical needs from the laboratory to the manufacturing floor. This role provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes f

CSV Lead Instrument Software Validation - 25-05061 100% Remote | CAD or USA 6+ Mths Duration W2/T4 or C2CNTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a CSV Lead Instrument Software Validation to join their team in Calgary, Ontario (CA-ON), Canada (CA).Job Description: Experience Level: 5-7 Years Job Descri

Responsibilities Data Validation: Analyze and validate data for accuracy, completeness, and consistency.Quality Assurance: Develop and implement data quality standards and processes.Issue Resolution: Identify and resolve data quality issues, ensuring compliance with regulations.Collaboration: Work with IT and data management teams to design and implement data strategies.Reporting: Generate data reports and presentations for management. Skill Strong experience in data validation and data quality

Job Title: QA/QC Data Validation Consultant Location: Remote Duration: (6-12 Months ) Responsibilities Data Validation: Analyze and validate data for accuracy, completeness, and consistency.Quality Assurance: Develop and implement data quality standards and processes.Issue Resolution: Identify and resolve data quality issues, ensuring compliance with regulations.Collaboration: Work with IT and data management teams to design and implement data strategies.Reporting: Generate data reports and pres

Skills: QA/QC Data Validation Location: Remote Responsibilities Data Validation: Analyze and validate data for accuracy, completeness, and consistency.Quality Assurance: Develop and implement data quality standards and processes.Issue Resolution: Identify and resolve data quality issues, ensuring compliance with regulations.Collaboration: Work with IT and data management teams to design and implement data strategies.Reporting: Generate data reports and presentations for management. Alteryx: Prof

Job Title: QA/QC Data Validation Consultant Job Location: (100% Remote) Job Duration: 12 Months contract with a possibility of extension Job Description: Data Validation: Analyze and validate data for accuracy, completeness, and consistency.Quality Assurance: Develop and implement data quality standards and processes.Issue Resolution: Identify and resolve data quality issues, ensuring compliance with regulations.Collaboration: Work with IT and data management teams to design and implement data s

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati

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

Job Title: Sr. Analyst, IT Validation Services Location: Remote Duration: 12 Months Pay Range: $30/hr-$35/hr on W2 (DOE) Primary Responsibilities Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls: Validation Plans/Summary Reports Risk Assessments User Requirements Specifications Test Plans Test Scripts: IQ, OQ or PQ Assess and implement the most effective validation strategy for each activity. Oversee test execution for c

Validation Lead FTE REMOTE Job/ Role Description Proven leadership in testing, validation for medium to large system implementations, ensuring GxP compliance and quality deliveryExtensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomesProficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reportingExpertise in HP ALM for managing testing cycles, with broad technical knowledge of SaaS and Clo

Job Description: Role: Technical Architect Location Remote Duration: Long Term Contract Job Summary The Technical Architect in Design Validation is responsible for conceptualizing, designing, and delivering innovative solutions that align with the defined scope and standards across various projects. This role plays a crucial part in ensuring that the architecture and design meet the highest quality standards, ultimately supporting the organization s objectives and enhancing client satisfaction

Title: Program Manager (Medicare Recovery Audit Validation) Location: Remote United States Company Background A P Ventures, LLC (APV) is an innovative Woman-Owned Small Business (WOSB) providing services to Government customers at the federal and state levels in three key focus areas: High-End IT Consulting, Emerging Technology and Training Solutions, and Human Capital Services. Established in 2007, APV has completed 70+ prime contracts and currently oversees 25+ task orders, consistently achi