validation Jobs

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Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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King of Prussia, Pennsylvania, USA

Full-time

Responsibilities: Designing and executing validation including support of computer system validation protocols to ensure consistency of data production and compliance with client's quality standards (including internal ISPE referenced guidelines, client procedures, and 21 Code of Federal Regulations Part 2XX and 8XX level standards which apply to the equipment and product being validated). Ensuring product and process development activities have all necessary validation and supporting justifica

Independent Verification & Validation (IV&V) Principal EngineerJob Title - Independent Verification & Validation (IV&V) Principal Engineer

Westinghouse Electric Company LLCCompany Name - Westinghouse Electric Company LLC

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Warrendale, Oregon, USA

Full-time

Are you interested in being part of an innovative team that supports Westinghouse's mission to provide clean energy solutions? At Westinghouse, we recognize that our employees are our most valuable asset and we seek to identify, attract and recruit the most qualified talent while recognizing and encouraging the value of diversity in the global workplace. About the role: We are seeking an experienced Principal Engineer to join our Independent Verification and Validation (IV&V) group supporting

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

Sr. Computer system Validation EngineerJob Title - Sr. Computer system Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Saint Joseph, Missouri, USA

Full-time

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 Manager. Enga

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Rockford, Illinois, USA

Full-time

Responsibilities: Perform validation activities to ensure compliance with government and customer requirements. Prepare and execute validation protocols (IOQ, OQ/PQ) and related documentation for new customer/product/system launches. Maintain existing validated processes, coordinating internal and customer approvals as needed. Ensure validation documentation is complete, accurate, and properly closed, including organizing and coordinating multiple approvals. Assist in the change control pro

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Marlborough, Massachusetts, USA

Full-time

Responsibilities: Derive test requirements from the design specifications, define test plan and methodology, estimate effort and resources plan to cover design verification and validation campaign. Establish acceptance criteria, sampling, assess through modeling or qualitative/quantitative testing, evaluate the performance according to URS, SRS (design inputs and outputs). Write test protocol, setup design of experiments, execute tests, analyse results and document reports for design verificati

Principal Engineer, ValidationJob Title - Principal Engineer, Validation

Novo Nordisk IncCompany Name - Novo Nordisk Inc

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Bloomington, Indiana, USA

Full-time

About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product f

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Summit, New Jersey, USA

Full-time

Position Overview: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses basic

Validation Engineer IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Waltham, Massachusetts, USA

Full-time

Responsibilities: Local Validation Program Maintenance. QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. V

Verification & Validation EngineerJob Title - Verification & Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Job description: As a member of the Vantive Acute Therapies Verification and Validation engineering team, you would be responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your expertise will be applied to all levels of product development from component prototypes to final system design. This will include developing, executing, and validating test methods/creating associated documentation. Int

Sr. CSV Validation EngineerJob Title - Sr. CSV Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - 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

Verification and Validation R&D EngineerJob Title - Verification and Validation R&D Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Marlborough, Massachusetts, USA

Full-time

Responsibilities: Designs, develops, and implements cost-effective methods of testing and troubleshooting systems and equipment. Prepares test and diagnostic plans/programs and infrastructure, designs test fixtures and equipment, and completes specifications and procedures for new products. Plans the labor, schedules, and equipment required for testing and evaluating standard and special devices. Lead and execute Verification and Validation (V&V) activities for disposable kit development. De

Sr. CSV Validation EngineerJob Title - Sr. CSV Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

Sr. Validation Engineer (CSV)Job Title - Sr. Validation Engineer (CSV)

Katalyst Healthcares and LifesciencesCompany Name - 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

Validation Engineer IJob Title - Validation Engineer I

Novo Nordisk IncCompany Name - Novo Nordisk Inc

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Lebanon, New Hampshire, USA

Full-time

About the Department Site New Hampshire, located in West Lebanon, is where Novo Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. What we offer you: Leading pay and annual performance bonus for all positions 36 Paid days off including vacation, sick days & company holidays Health Insurance, Dental Insurance, Vision Insurance Gua

Executive - Product Validation Test Enabling Systems LeaderJob Title - Executive - Product Validation Test Enabling Systems Leader

GE AerospaceCompany Name - GE Aerospace

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Evendale, Ohio, USA

Full-time

Job Description Summary The Product Validation Test Enabling Systems Leader will be responsible for the design, project management, fabrication and delivery of all test facilities & infrastructure, auxiliary engine test hardware, and auxiliary rig test hardware design. Test Enabling Systems will direct the efforts of Test Enabling Hardware & Facilities, and Development Machining Operations (DMO) teams. Job Description Essential Responsibilities: Direct/execute test enabling hardware, test infr

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Pittsburgh, Pennsylvania, USA

Full-time

Roles & Responsibilities: They have a project to validate some of their new printers and prefer to use contractors to complete the 6-month project. The Senior Process Validation engineer will be in charge of procedure changes, validation efforts for existing processes and the changes created during this time. They are expected to have experience writing procedures and validating some printers, while validating some of the software pieces to the printers. 7-12+ Years of experience with Proc

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Pomona, California, USA

Full-time

Roles & Responsibilities: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment,

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Pomona, California, USA

Full-time

Responsibilities and requirements: 6 to 8 years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics). Non-Product software validation for Manufacturing Equipment's as per Regulatory standards (FDA, ISO requirements). Prepare, review functional requirements, design and testing documents. Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk a