Senior Validation Engineer Jobs

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Senior Validation EngineerJob Title - Senior Validation Engineer

Zachary Piper Solutions, LLCCompany Name - Zachary Piper Solutions, LLC

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Copiague, New York, USA

Full-time

Piper Companies is seeking a Senior Validation Engineer to join a leading pharmaceutical manufacturing company located in Long Island, NY. The Senior Validation Engineer will ensure compliance by developing and executing testing protocols for equipment, processes, and utilities in a pharmaceutical cGMP environment. Responsibilities of the Senior Validation Engineer include: Manage end to end, hands on, validation for products, processes, equipment and packaging Supports all qualification tasks

Senior Validation EngineerJob Title - Senior Validation Engineer

Thermo Fisher ScientificCompany Name - Thermo Fisher Scientific

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Allentown, Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) 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

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

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

Sr Validation EngineerJob Title - Sr Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Columbia, Maryland, USA

Full-time

Responsibilities: Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment. Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team. Excellent leadership skills include the ability to simultaneously organize, and successfully execute

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Jacksonville, Florida, USA

Full-time

Responsibilities: Designing validation plans. Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes. Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits. Designing and executing engineering studies for critical process p

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Indianapolis, Indiana, USA

Full-time

Responsibilities: Lead the development and execution of commissioning, qualification, and validation protocols for a range of laboratory equipment, facility systems, and utilities. Draft, review, author, and deploy all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, and so on. Provide technical expertise throughout the validation lifecycle including risk assessment, deviation investigation, and change control activiti

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: 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

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Vacaville, California, USA

Full-time

Responsibilities: Supervisor Principal Validation Engineer. Responsible for defining qualification / validation strategies and coordinating testing activities required to complete assigned projects in support of continued cGMP operations at the Polaris Vacaville commercial manufacturing facility. This consists of initial qualification, requalification, periodic review and Validation activities associated with capital/expense projects. Performance of such validation activities includes equipment

Digital Platform Senior Validation EngineerJob Title - Digital Platform Senior Validation Engineer

Merck KgaACompany Name - Merck KgaA

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St. Louis, Missouri, USA

Full-time

Work Location: St. Louis, Missouri Shift: No Department: LS-QR-DV Validation Management Recruiter: Kathy Lewison Hiring Manager: Anbukumar Marimuthu This information is for internals only. Please do not share outside of the organization. Your Role: In this role, you will be the Digital Platform Senior Validation Engineer. This position is responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, and computerized systems. Yo

Sr. Software Validation EngineerJob Title - Sr. Software Validation Engineer

TalascendCompany Name - Talascend

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Newark, California, USA

Contract

Talascend is currently seeking an experienced Sr. Software Validation Engineer for a contract-to-direct career opportunity with our client on-site in Newark, CA. Candidates must be eligible to work for any employer without sponsorship now, or in the future. W-2 only. Relocation at the candidate s expense will be considered. This role does not support remote or hybrid work. Overview The engineer will work collaboratively with a team responsible for cybersecurity of embedded systems (ECUs); per

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

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

Sr. Application Validation EngineerJob Title - Sr. Application Validation Engineer

SUPERMICRO COMPUTER INCCompany Name - SUPERMICRO COMPUTER INC

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San Jose, California, USA

Full-time

Job Req ID: 26062 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data, Hyperscale, HPC and IoT/Embedded customers worldwide. We are the #5 fastest growing company among the Silicon Valley Top 50 technology firms. Our unprecedented global expansion has provided us with the opportunity to offer a large number of new positions to the technology community. We seek talented, pass

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

Sr. Staff Post Silicon Validation Engineer - Direct hire/Full time (Onsite)Job Title - Sr. Staff Post Silicon Validation Engineer - Direct hire/Full time (Onsite)

Maxonic, Inc.Company Name - Maxonic, Inc.

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Austin, Texas, USA

Full-time

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Sr. Staff Post Silicon Validation Engineer Job Description: Job Title: Sr. Staff Post Silicon Validation Engineer Job Type: Fulltime Job Location: Austin, TX or Palo Alto, CA Work Schedule: Onsite 5 days a week The candidate will focus on developing Post-Silicon validation plan, debug tools, and infrastructure for a custom SoCs and Platform designs for Autopilot and AI. As

Senior Hardware Validation EngineerJob Title - Senior Hardware Validation Engineer

NVIDIA CorporationCompany Name - NVIDIA Corporation

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Santa Clara, California, USA

Full-time

NVIDIA has continuously reinvented itself over two decades. Our invention of the GPU in 1999 sparked the growth of the PC gaming market, redefined modern computer graphics, and revolutionized parallel computing. More recently, GPU deep learning ignited modern AI - the next era of computing. NVIDIA is a "learning machine" that constantly evolves by adapting to new opportunities that are hard to solve, that only we can tackle, and that matter to the world. This is our life's work, to amplify human

Sr. Process Validation EngineerJob Title - Sr. Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Grand Rapids, Michigan, USA

Full-time

Roles & Responsibilities: Minimum 7 years of CQV experience in a parenteral fill/finish environment. Lead process validation projects of broad scope. Responsible for project deliverables such as VMPs, pFMEAs, PPQ protocols and reports, change control assessments, technical transfer assessments, as well as other client deliverables as required. Provide technical support to Manufacturing - troubleshooting and resolving process related issues. Participate in investigations and provide documentation

Sr Process Validation EngineerJob Title - Sr Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Grand Rapids, Michigan, USA

Full-time

Roles & Responsibilities: Lead process validation projects of broad scope. Collaborate with clients, Validation, and cross-functional team members to coordinate projects, resolve issues, and meet aggressive timelines. Represent Validation in customer interactions and communicate customer requirements to the broader Validation team as needed. Oversee execution of process validation (PPQ) protocols on the production floor on varying shifts as needed to ensure that protocol requirements are satisfi