Senior Validation Lead Jobs

201 - 220 of 295 Jobs

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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East Windsor, New Jersey, USA

Full-time

Responsibilities: Previous experience as a validation engineer in an aseptic pharmaceutical fill/finish environment. Prior experience executing validation protocols on a pharmaceutical fill/finish line. Specific line components include. Lyophilizers. Depyrogenation tunnels. Autocalves. Previous experience with the project management requirements of validation project in a GMP environment. Requirements: Managing validation schedule. Communication of delays and changes to timelines. Coor

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Piscataway, New Jersey, USA

Full-time

Position Overview: Looking for an individual with experience in validations particularly with USP Water, chiller (utilities) and C&S. Responsibilities: Generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, adhering to project timelines, ensure compliance with company and industry standards and participating in cross-functional teams. Required Skills: Experience with drafting and executing IQ / OQ / PQ. CAD proficiency to

Lab Equipment Validation EngineerJob Title - Lab Equipment Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Philadelphia, Pennsylvania, USA

Full-time

Responsibilities: Our client is looking for a lab equipment validation engineer to come on-site for a 6 months project. This work will be fully on-site in PA. They are moving buildings, so all of the Laboratory equipment will be decommissioned and then put in the new building. They need this Consultant to come in and requalify, revalidate, and commission the Laboratory Equipment. They will also be getting some new Laboratory Equipment in as well - HPLC, Cell Counters.Requirements: This Consultan

Validation Engineer IIJob Title - Validation Engineer II

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Athens, Georgia, USA

Full-time

Responsibilities: Perform Smoke studies and assist in semiannual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas. Has worked with Ellabs data loggers and software. Write and execute protocols and complete final reports. Understanding of cleaning validation concepts and principles. Understands pharma grade utilities (water HVAC, gases). Requirements: Support Maintenance, Engineering

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Danvers, Massachusetts, USA

Full-time

Roles & Responsibilities: Process Validation (IQ/OQ/PQ). Product development experience. Process development. Process Layout, Modeling, and Documentation. Equipment and Tooling Development. Process Development and Characterization. Test Method Development and Validation. Developing / Updating MPIs. Supplier Development and Component Engineering. Manufacturing Engineering Support / Engineering Documentation. Update work instructions to match the practice on the floor to what's in the p

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Swiftwater, Pennsylvania, USA

Full-time

Roles & Responsibilities: Bachelor's degree in science or engineering (MS accepted, PhD is overqualified). Minimum 2+ years in Process Validation within the biotech/pharma industry. Writing and executing process validation documents. Strong Process Performance Qualification (PPQ) experience. Hands-on experience collecting process samples. Must have on-the-floor manufacturing experience. Familiarity with GMP best practices. Proficient in MS Office (Word, Excel, PowerPoint). Strong w

System Validation Software EngineerJob Title - System Validation Software Engineer

Apple, Inc.Company Name - Apple, Inc.

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No location provided

Full-time

The Product Integrity group is seeking a System Validation Software Engineer to help validate and debug future products. As part of the OS Diagnostics team, you will be responsible for crafting and maintaining software applied for characterizing, calibrating, and testing novel hardware. Your duties will also include debugging software and hardware independently and multi-functionally, and working with numerous other teams within Apple and with various contract manufacturers. Your proficiency in

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irvine, California, USA

Full-time

Responsibilities: NPD, NPI, Process & product development. Process and Equipment Validation. Process Characterization. good manufacturing practices and documentation. Process Improvement. Requirements: GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs. Knowledge in Experiment design and SPC. Management of statistical procedures. Strong creative, analytical and problem-solving skills. Comprehension of standard costs and

Verification & Validation EngineerJob Title - Verification & Validation Engineer

PeopleNTechCompany Name - PeopleNTech

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Branford, Connecticut, USA

Contract, Third Party

Role: Verification & Validation Engineer Location: Northford CT (complete onsite) Experience: 8+ Years What candidate will Be Doing: Product validation activities both Manual and Automation testingExtending the internally developed custom test framework (involves robotics, computer vision, distributed computing and sensor simulation) and utilizing the framework to perform testsExtending the framework hardware test fixtureDefining and developing automated test plans, test cases, and proceduresDe

Validation EngineerJob Title - Validation Engineer

AdientOne LLCCompany Name - AdientOne LLC

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Texas, USA

Contract

Role: Validation Engineer Location: Austin TX 78735 | Hybrid Duration: 12+ months Notes: We are looking for an engineer with experience in power or performance attainment of features of CPU, GPU, or APUs. This person should thrive in a matrixed environment spanning multiple countries and time zones. Job Duties: In this role, this engineer will be part of a highly technical team that develops test plans, completes functional & electrical validation, & debugs issues for new processor silicon inte

Network Validation EngineerJob Title - Network Validation Engineer

SUPERMICRO COMPUTER INCCompany Name - SUPERMICRO COMPUTER INC

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San Jose, California, USA

Full-time

Job Req ID: 26847 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

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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St. Louis, Missouri, USA

Full-time

Responsibilities: Provide technical support and routine process monitoring for commercial products manufactured at CMOs. Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team. Reviews manufacturing processes, deviations, and/or development and production data. Reviews manufacturing batch records, protocols, and control strategies. Provide technical support and data analysis for investigations and deviation resolution. Recommen

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Waltham, Massachusetts, USA

Full-time

Responsibilities: Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution. Ensure deliverables meet the overall facility milestones. Perform and support periodic assessment review and revalidation activities. Ensure deliv

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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St. Louis, Missouri, USA

Full-time

Responsibilities: The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. Our Engineers are responsible for protocol writing and execution (field verification), and development of summary reports. Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines. Ability to work independently. Support onsite and offsite activities, such as: FATs, SATs, IOQ

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Los Angeles, California, USA

Full-time

Responsibilities: Coordinate sample builds and maintain traceability documentation. Prepare process validation protocols (IQ/OQ/PQ) and generate accompanying test plans/reports. Route and track all protocol documents for proper approvals. Characterize new process equipment. Document experiments and results in engineering reports. Create and present summary presentations to management. Collaborate and coordinate with outside vendors. Provide technical support to engineering and provide li

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Mossville, Illinois, USA

Full-time

Responsibilities: ssess and plan work to mitigate risk in NTI and NPI programs. Work with design leads to establish an initial first-pass test plan early in a program (pick list review to document leverage opportunity, VPD and potential test load). Participate in or Plan and Host Simulation and Test Collaboration Workshops (STCW) early in programs, pre-DFMEA to create high-level Validation Plan. Communicate progress in Gateway Reviews including System Readiness Summaries. Quality approval of FME

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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South Carolina, USA

Full-time

Responsibilities: Provide technical input to validation activities. Represent process validation during equipment installations. Support process validation Quality Systems. Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices. Participate in regulatory agency inspections for Process Validation. Serve as one of the main points of contact in communication to customers whose equipment and processes are being validate. Responsible

Product and Validation SME EngineerJob Title - Product and Validation SME Engineer

Texas InstrumentsCompany Name - Texas Instruments

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Dallas, Texas, USA

Full-time

Job Description Change the world. Love your job. About the job: This is a unique position and offers a great opportunity to work on TI's most advanced custom products. In this role, as a Subject Matter Expert (SME) for product and validation engineering, you will have visibility and responsibility for driving execution excellence across the company on projects for TI's largest customer. Your expertise will be called upon to solve the hardest customer issues, and in parallel, train TI product l

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Thousand Oaks, California, USA

Full-time

Responsibilities: Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines. Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment. Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equi

Site Validation EngineerJob Title - Site Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Holdrege, Nebraska, USA

Full-time

Responsibilities: Support the plant on assigned new and existing product initiatives with technical expertise and determine associated resource needs to accomplish project goals. Develop and maintain the Validation Master Plan and validation tracking schedule. Provide visibility related to all validation activities through tracking and reporting plant metrics. Support and influence change management within the plant: liaison between the core team, program managers, and Global quality. Conduct tr