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Lead Engineer, Quality Validation

Katalyst Healthcares and Lifesciences

Andover, Massachusetts, USA

Full-time

Job Description: The contract Lead Engineer, Quality Validation will be responsible for providing quality and technical support for qualification and validation activities related to laboratory instruments, temperature control units and LFH/BSC units for internal customers. The individual will support and facilitate the review and approval of qualification/validation documentation for all stages of the equipment life cycle qualification process. Responsibilities: Provide quality oversight of Bl

Control Systems Test Validation Manager

Trane Technologies

Minneapolis, Minnesota, USA

Full-time

Job DescriptionAt Trane TechnologiesTM and through our businesses including Trane and Thermo King , we create innovative climate solutions for buildings, homes, and transportation that challenge what s possible for a sustainable world. We're a team that dares to look at the world's challenges and see impactful possibilities. We believe in a better future when we uplift others and enable our people to thrive at work and at home. We boldly go. \n \nWhat s in it for you: \nBe a part of our missio

Senior SSD Validation Engineer

Micron Technology, Inc.

Longmont, Colorado, USA

Full-time

Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. Act as the subject matter expert for validation on customer test requirements and results. Review and challenge current test plans, coverage, and testing activities to drive both increased effectiv

Quality Assurance Engineer - Process and Validation

Civica Rx

Petersburg, Virginia, USA

Full-time

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs

Validation Engineer

Katalyst Healthcares and Lifesciences

Huntington, Texas, USA

Full-time

Roles & Responsibilities: M.S. in Engineering or Biomedical Engineering 1+ year of professional experience in a Medical Device Manufacturing Environment Lead, execute, document & manage the validation activities (IQ/OQ/PQ) necessary to support the introduction or revision of automated and semi-automated production equipment and processes for Ophtalmic medical devices Design, develop, validate and implement manufacturing processes to build opthalmic medical devices for cataract and vitroreti

Process Validation Engineer

Katalyst Healthcares and Lifesciences

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

Network Validation Engineer

SUPERMICRO COMPUTER INC

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

Validation Engineer

Katalyst Healthcares and Lifesciences

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 Engineer

Katalyst Healthcares and Lifesciences

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 Engineer

Katalyst Healthcares and Lifesciences

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

Validation Engineer, Sterile & Cleaning

Katalyst Healthcares and Lifesciences

Bedford, Massachusetts, USA

Full-time

Responsibilities: We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams. Develop and execute

Validation Engineer

Katalyst Healthcares and Lifesciences

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

Validation Engineer

Katalyst Healthcares and Lifesciences

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 Engineer

Katalyst Healthcares and Lifesciences

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

Process Validation Engineer

Katalyst Healthcares and Lifesciences

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

Technical Lead - Validation, Tools, and Acceleration (VTA)

General Motors

Remote

Full-time

Job Description Remote: This role is based remotely but if you live within a 50-mile radius of [Atlanta, Austin, Detroit, Warren, Milford or Mountain View ], you are expected to report to that location three times a week, at minimum. Role Overview: As a Technical Lead within the Validation, Tools, Acceleration (VTA) team under the Simulation, Evaluation, and Data organization, you will be a senior individual contributor building and optimizing the infrastructure and required technology for all

Validation Engineer

Katalyst Healthcares and Lifesciences

Los Angeles, California, USA

Full-time

Responsibilities: Conceives, plans and executes manufacturing process validations plans and studies. dhere to the Change Control and Design Control requirements. To create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's. Being the lead on the writing and execution of IQ/OQ/PQ protocols. RCH/PCH - Routing in MAP Agile & follow up till release. Updating Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD). Preparing protocol & executing Test Meth

Validation Engineer

Katalyst Healthcares and Lifesciences

Oceanside, California, USA

Full-time

Responsibilities: Lead or support cleaning, equipment, utilities, sterilization and/or autoclave qualification due to equipment modifications for tech transfers, Make-Assess-Release (MAR) or routine re-qualification activities. Ensure the timely completion of Cleaning Monitoring as well as validation team assignments. Any deviations, anomalies or schedule impacting items are to be reported to site management. This position provides trained technical resources for the development and executio

Site Validation Engineer

Katalyst Healthcares and Lifesciences

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

Wireless Product Validation Engineer

Apple, Inc.

No location provided

Full-time

Are you an accomplished engineer with a passion for solving intricate challenges that directly impact the success of an organization? We are the Product Systems Quality organization, and we are looking for a Wireless Product Validation Engineer. We work cross-functionally with Hardware Engineering, Hardware Technology, and Software Engineering. We focus on the end user performance and play a critical role in shipping high quality Apple products! You will be responsible for developing, designing,