thermal validation engineer Jobs

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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

GXP Validation EngineerJob Title - GXP Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boca Raton, Florida, USA

Full-time

Responsibilities: 12 years' Experience in Validating systems and Experienced in GxP related applications. Perform review for GxP systems to ensure compliance with regulatory requirements as per the customer SOPs. Expertise on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis Adept with Agile and Waterfall methodology. Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test scr

Verification & Validation EngineerJob Title - Verification & Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plymouth, Minnesota, USA

Full-time

Job description: As a member of the Vantive Acute Therapies Verification and Validation engineering team, you would be 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 design. This will include developing, executing, and validating test methods/creating associated documentation. Int

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Philadelphia, Pennsylvania, USA

Full-time

Job Summary The Validation Engineer is responsible for executing equipment and system validation activities within a regulated biopharmaceutical environment. This role involves implementing validation protocols, documenting results, and ensuring compliance with regulatory requirements. The position is based in West Philadelphia, Pennsylvania with a hybrid work arrangement. Responsibilities: Proficiency in Kaye AVS validation software. Experience with Valpro validation management systems. Compet

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Albany, New York, USA

Full-time

Responsibilities: Execute validation activities across the full equipment lifecycle (FAT, SAT, Commissioning, DQ, IQ, OQ, PQ). Apply GAMP 5 methodology in a GMP-regulated environment. Support Greenfield project initiatives and equipment startup. Handle deviations, change controls, and validation deliverables. Collaborate with cross-functional teams including QA, Engineering, and Manufacturing. Requirements: Prior experience with fill-finish equipment including syringe assembly, serializati

Verification and Validation R&D EngineerJob Title - Verification and Validation R&D Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Marlborough, Massachusetts, USA

Full-time

Responsibilities: Designs, develops, and implements cost-effective methods of testing and troubleshooting systems and equipment. Prepares test and diagnostic plans/programs and infrastructure, designs test fixtures and equipment, and completes specifications and procedures for new products. Plans the labor, schedules, and equipment required for testing and evaluating standard and special devices. Lead and execute Verification and Validation (V&V) activities for disposable kit development. De

Validation Engineer IIIJob Title - Validation Engineer III

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Plainsboro Township, New Jersey, USA

Full-time

Job Description: Qualified candidates must be experienced in one or more of the following areas of validation: Equipment Qualification Process Qualification The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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San Juan, San Juan, Puerto Rico

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments. Test planning and strategy. creation and execution of test protocols, scripts and reports.

Validation Engineer NPIJob Title - Validation Engineer NPI

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Irving, Texas, USA

Full-time

Roles and responsibilities: NPI Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), pFMEA and dFMEA. 3+ years of experience & demonstrated proficiency in New Product Introduction, Windchill PLM & providing ongoing technical support is preferred. Under limited supervision, performs and documents moderately complex technical functions relating to test, quality control, Client-out, fabrication, modification, and assembly of mechanical

System Verification and Validation EngineerJob Title - System Verification and Validation Engineer

JacobsCompany Name - Jacobs

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Houston, Texas, USA

Full-time

Are you passionate about human space exploration, understanding the origins of the universe, and working with a passionate and diverse team to make a difference? If you are, we need you! We need your talent, teamwork, and energy to help us achieve great things that inspire people all over the globe. We need you to bring creative ideas and diverse backgrounds to help us envision, shape, and deliver systems that will enable the exploration of space while benefiting people here on Earth. We are exc

Lead Engineer, Quality ValidationJob Title - Lead Engineer, Quality Validation

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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

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: Conceives, plans and executes manufacturing process validations plans and studies. Adhere 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 Te

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Princeton, New Jersey, USA

Full-time

Roles & Responsibilities: Develop and execute validation protocols for computer systems. Ensure compliance with regulatory requirements and industry standards. Create detailed validation documentation including plans, reports, and scripts. Conduct risk assessments and impact analyses related to computer systems. Coordinate and supervise testing activities. Collaborate with cross-functional teams to maintain and improve system validation processes. Monitor and report on validation project

Risk Quantitative Model Validation AnalystJob Title - Risk Quantitative Model Validation Analyst

Regions Financial CorporationCompany Name - Regions Financial Corporation

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Birmingham, Alabama, USA

Full-time

Thank you for your interest in a career at Regions. At Regions, we believe associates deserve more than just a job. We believe in offering performance-driven individuals a place where they can build a career a place to expect more opportunities. If you are focused on results, dedicated to quality, strength and integrity, and possess the drive to succeed, then we are your employer of choice. Regions is dedicated to taking appropriate steps to safeguard and protect private and personally identifi

Mid/Senior Level Validation Specialist/EngineerJob Title - Mid/Senior Level Validation Specialist/Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Pennsylvania, USA

Full-time

Roles & Responsibilities: Minimum of Four (4) years of experience with commissioning and qualification including using ISPE C&Q guidelines. Knowledge of Kneat e validation software preferred. Prior experience with analytical instrumentation qualification and controlled temperature unit qualification is required. Strong technical writing skills, verbal and written communication skills. Strong interpersonal skills (requires interaction with client employees). Responsible for the development an

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

Computer System Validation EngineerJob Title - Computer System Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V

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

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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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