thermal validation engineer Jobs

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Data Validation AnalystJob Title - Data Validation Analyst

ComericaCompany Name - Comerica

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Farmington Hills, Michigan, USA

Full-time

Data Validation Analyst The Data Validation Analyst position is a role within Loan Closing and is responsible for reviewing data contained in the loan approval document to confirm integrity of data entered in bank systems. This position is also responsible for entering data upon completion of validation of data integrity and is a partner to the Loan Closing Officers in advancing an approved transaction from credit approval through booking on the loan accounting system. Position Competencies Suc

Data Validation AnalystJob Title - Data Validation Analyst

ComericaCompany Name - Comerica

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Farmington Hills, Michigan, USA

Full-time

Director, Test and Validation, Electronics ProductsJob Title - Director, Test and Validation, Electronics Products

Harman InternationalCompany Name - Harman International

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Richardson, Texas, USA

Full-time

A Career at HARMAN As a technology leader that is rapidly on the move, HARMAN is filled with people who are focused on making life better. Innovation, inclusivity and teamwork are a part of our DNA. When you add that to the challenges we take on and solve together, you'll discover that at HARMAN you can grow, make a difference and be proud of the work you do every day. Introduction: A Career at HARMAN Lifestyle We're a global, multi-disciplinary team that's putting the innovative power of tec

Validation Engineer with cGMPJob Title - Validation Engineer with cGMP

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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South Carolina, USA

Full-time

Job Description: This position is responsible for writing, implementing, analysing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. Will include developing and accessing following the Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validat

Validation Support EngineerJob Title - Validation Support Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Job Description: We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment. The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards. Responsibilities: Develop/update Validation Plans (VP) and Master Validation Plans (MVP). Lead GxP risk assessments for system changes. Author and

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

CSV Engineer (Computer System Validation)Job Title - CSV Engineer (Computer System Validation)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Kansas City, 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. Engage

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, functions, and uses basi

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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Warsaw, Indiana, USA

Full-time

Responsibilities: Develops and Executes Cleaning Validation Strategies: Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective cleaning processes for medical devices and equipment. Ensures Regulatory Compliance: Adheres to FDA (21 CFR 820), ISO 13485, and other relevant regulations, participating in audits and maintaining up-to-date knowledge. Analyzes Data and Reports Findings: Compiles and analyzes validation data, writes comprehensive reports, and identifies trends

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

CSV Engineer (Computer System Validation)Job Title - CSV Engineer (Computer System Validation)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Kansas City, Missouri, USA

Full-time

Roles & 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 Manage

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Springfield, Illinois, USA

Full-time

Job summary: Seeking a Facilities Validation Specialist who will be responsible for working across two state-of-the-art medical device facilities. They will have a long-term contract position with significant project ownership an opportunity to work with advanced cleanroom environments and warehouse facilities. Responsibilities: Lead facility commissioning activities across multiple sites. Conduct temperature and humidity mapping studies. Perform cleanroom validation for Class 6, 7, and 8 envi

Utilities Qualification(Validation) EngineerJob Title - Utilities Qualification(Validation) Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Salt Lake City, Utah, USA

Full-time

Job Description: A pharmaceutical/biotech client in Utah is seeking a mid-to-senior level Utilities Qualification Engineer with 5+ years of experience in critical utilities validation and qualification. The candidate will support GMP manufacturing operations by qualifying and documenting systems like AHUs, purified water, compressed air, and legacy cleanroom systems. This is a fully onsite role and requires a self-driven individual with hands-on experience in IQ/OQ/PQ, EDMS tools (Glorya

Validation Engineer IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Responsibilities: Ensure that all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm that they function correctly and meet operational specifications. Validate manufacturing processes to ensure they are capable of consistently producing products that meet quality standards. This includes processes like blending, cutting, rolling, and packaging. Regularly revali

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

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Nashville, Tennessee, USA

Full-time

Responsibilities: Ensure all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergoes: These confirm proper functionality and adherence to operational specifications. Validate manufacturing processes (e.g., blending, cutting, rolling, and packaging) to ensure consistent production of high-quality products. Conduct revalidation of equipment and processes when changes occur, such as: ssess risks related to equipment, processes, and production areas that could impact product qua

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Fall River, Massachusetts, USA

Full-time

Job Description: The Validation Engineer is responsible for developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications, ensuring that automated process equipment that mass produce medical device consumables and other products, are designed, developed or changed in compliance with specifications, requirements, safety and Company and regulatory guidelines. The Validation Engineer will work closely with Senior validation staff, maintenance, operations, and R&D teams t

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