process validation engineer Jobs

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Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Colorado, USA

Full-time

Job Description: Process Validation Engineer with 5+ years of engineering experience. This role includes an in-depth training program, where the consultant will be paired with a team member to review training materials and receive hands-on floor training related to process validation and supplier quality activities. The engineer will work cross-functionally to assess manufacturing and supplier quality processes, identify improvement opportunities, and implement effective solutions. Strong c

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Colorado Springs, Colorado, USA

Full-time

Responsibilities: Lead and manage the Process Validation and Verification qualification at the plastic suppliers and other commodities across IGTD portfolio. Looking to hire somebody with Manufacturing Engineering and Design expertise to review the Specification of Product and Part requirement with R&D and design assurance against of part/product risk management file. Hands on driving and performing IQ, OQ, PQ and TMV at the suppliers. Strong Communicator to manage stakeholders and provide b

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Albany, Georgia, USA

Full-time

Responsibilities: Spearhead qualification protocols for next-generation manufacturing processes. Drive manufacturing investigations and implement innovative solutions. Design validation strategies for new product launches and technology transfers. Lead comprehensive IQ/OQ/PQ validation activities across multiple projects. Create robust standard operating procedures for manufacturing excellence. Ensure continuous process verification for robust manufacturing operations. Coordinate cross-fu

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

Process Validation EngineerJob Title - Process Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Austin, Texas, USA

Full-time

Responsibilities: Author, review, and execute validation protocols (IQ, OQ, TMV, PQ) for process validation and re-validation activities in compliance with FDA/AAMI/ISO/EN guidelines/standards. Actively participate in all phases of process qualification. Evaluate projects, provide guidance and technical information, generate protocols, execute qualification activities, analyze data, and prepare reports. Lead all assigned qualification activities and make independent decisions related to thes

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

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

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

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

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

Principal Process Controls & Validation EngineerJob Title - Principal Process Controls & Validation Engineer

Regeneron PharmaceuticalCompany Name - Regeneron Pharmaceutical

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Remote or Rensselaer, New York, USA

Full-time

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

Systems Qualification Validation Engineer with MES/OT -OnsiteJob Title - Systems Qualification Validation Engineer with MES/OT -Onsite

BURGEON IT SERVICES LLCCompany Name - BURGEON IT SERVICES LLC

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Indianapolis, Indiana, USA

Contract, Third Party

Role: Systems Qualification Validation Engineer with MES/OT Location: Indianapolis, Indiana Onsite Long term Contract Share the resumes with ajithatburgeonitsdotcom Domain: CSV Life Science JD: OT system Qualification and validation is Must Mandatory Skills: Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), PAS/DCS Integrated with Manufacturing Equipment qualification. De

Data Engineer for HSIO Validation - IntermediateJob Title - Data Engineer for HSIO Validation - Intermediate

Cynet SystemsCompany Name - Cynet Systems

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Remote or Austin, Texas, USA

Contract

Job Description: Responsibilities: Implement automation and data stXXgy with validation technical leads and data architects to reduce time to market and time to quality. Develop Python automation scripts for performance metrics data collection and characterization. Deliver robust data analytics solutions for visualization, results reporting, and building predictive statistical models. Develop database solutions to support storage and analysis of test results from validation and manufacturing. I

Validation EngineerJob Title - Validation Engineer

LanceSoft Inc.Company Name - LanceSoft Inc.

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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

Validation EngineerJob Title - Validation Engineer

StefaniniCompany Name - Stefanini

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Minneapolis, Minnesota, USA

Contract

Stefanini Group is hiring! Stefanini is looking for Validation Engineer in Plymouth, MN For quick Apply, please reach out to Sangeeta Dasadhikary- call: / email: Work Hours: M-F (40 hours) Work Location: Plymouth, MN Shift: 1st Shift 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

Validation EngineerJob Title - Validation Engineer

Shimento, Inc.Company Name - Shimento, Inc.

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Portsmouth, New Hampshire, USA

Contract

Title: Analytical Validation Specialist IV Location: Portsmouth, NH Long Term Oniste Lead validation activities for analytical equipment, including software updates, new installations, and decommissioning.Act as Subject Matter Expert (SME) for analytical systems across Quality Control, Manufacturing, and other departments.Plan and execute validation protocols (IQ/OQ/PQ) for equipment and system changes.Manage and maintain TW records, including Change Controls, CAPAs, and Deviations.Create and r

Process Validation SpecialistJob Title - Process Validation Specialist

SGS ConsultingCompany Name - SGS Consulting

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Plainsboro Township, New Jersey, USA

Contract

Job Title: Validation Engineer Duration: 06 Months + (Possible Extension) Location: Plainsboro, NJ 08536 (Onsite) Schedule: Business Hours Job Description: Qualified candidates must be experienced in one or more of the following areas of validation: Equipment QualificationProcess Qualification Summary Description: Responsibilities associated with this position are directly associated with the introduction and launching of new equipment or products and processes into a manufacturing facility.Th

Instrument Verification and Validation Engineer (Medical Device)Job Title - Instrument Verification and Validation Engineer (Medical Device)

CaresoftCompany Name - Caresoft

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Rochester, New York, USA

Contract

Job Summary for Sr. Instrument Verification and Validation Engineer - Lead formal verification and validation (V&V) activities for complex medical devices in compliance with FDA regulations. - Design and implement software for embedded devices and systems, including developing, coding, testing, and debugging system software. - Develop and execute requirements-based manual test cases and procedures in a BL2 lab environment. - Analyze test results, document findings, and manage system software

Thermal Validation EngineerJob Title - Thermal Validation Engineer

Fusion Global SolutionsCompany Name - Fusion Global Solutions

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Sunnyvale, California, USA

Full-time

Position: Thermal Validation Engineer Location: Sunnyvale, CA 100% Onsite Exp: 1-5 Yrs Job Summary: We are seeking a Thermal Validation Engineer with experience in characterizing the thermal performance of high-volume, battery-operated consumer electronics. The ideal candidate will excel in creating real-world thermal conditions in laboratory environments and have a strong background in data analysis to drive design improvements. Key Responsibilities: Develop and execute comprehensive therma

Senior Validation EngineerJob Title - Senior Validation Engineer

Cloud Destinations LLCCompany Name - Cloud Destinations LLC

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Santa Clara, California, USA

Contract

Job Summary: We are looking for a highly skilled Senior Validation Engineer to lead the testing and validation of semiconductor components, data center hardware, and GPUs. Must have strong experience in System Level Validation, which includes rack level systems as well as tray level systems. This role requires deep expertise in designing, executing, and analyzing validation tests, as well as hands-on experience with Python scripting for test automationand software testing methodologies. The idea