Validation & Compliance Engineer Jobs

61 - 80 of 1,066 Jobs

Sr Validation EngineerJob Title - Sr Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Columbia, Maryland, USA

Full-time

Responsibilities: Responsible for preparing, executing commissioning and qualification documents for a variety of utilities, facility, and process equipment. Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment. Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team. Excellent leadership skills include the ability to simultaneously organize, and successfully execute

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

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

Analytical Test Method Validation EngineerJob Title - Analytical Test Method Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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South Plainfield, New Jersey, USA

Full-time

Develop, validate, and implement analytical test methods for combination products in compliance with regulatory standards and internal quality requirements. Collaborate cross-functionally with device engineers, laboratory teams, and quality departments to ensure alignment and successful execution of test method validation (TMV) activities. Provide expert guidance on analytical strategies for device-related products, ensuring robust and reproducible methods are established. Evaluate and optimize

Sr. Validation Engineer (CSV)Job Title - Sr. Validation Engineer (CSV)

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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California, USA

Full-time

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Indianapolis, Indiana, USA

Full-time

Responsibilities: Lead the development and execution of commissioning, qualification, and validation protocols for a range of laboratory equipment, facility systems, and utilities. Draft, review, author, and deploy all required validation documentation including IQ/OQ/PQ protocols, reports, master plans, risk assessments, procedures, reports, and so on. Provide technical expertise throughout the validation lifecycle including risk assessment, deviation investigation, and change control activiti

Signature Assessment and Validation Engineer (Lead or Senior)Job Title - Signature Assessment and Validation Engineer (Lead or Senior)

Boeing CompanyCompany Name - Boeing Company

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Berkeley, Missouri, USA

Full-time

Signature Assessment and Validation Engineer (Lead or Senior) Company: The Boeing Company The Boeing Defense, Space & Security (BDS) - Phantom Works organization is seeking Signature Assessment and Validation Engineers to join the Signature Integrity Team in St. Louis, Missouri region. This is a great opportunity for someone to help enable stealth performance of platforms through manufacturing and operation processes. Signature Assessment and Validation (SAV) engineers work closely with QA an

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

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Responsibilities: Develop and implement comprehensive validation plans for packaging lines, labelers, case packers, and low-speed pen assembly. Lead the validation of various systems, including SEA Vision Yudoo and AVI systems, ensuring compliance with industry standards and regulatory requirements. Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Collaborate with cross-functi

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Richmond, Virginia, USA

Full-time

Equipment Validation Engineer IIJob Title - Equipment Validation Engineer II

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Responsibilities: Authoring and/or reviewing of SOP's (both new and existing). Authoring and/or reviewing Equipment Requirements Specifications. Document calibration and maintenance requirements, generate procedures. Supporting Equipment Management Program. Schedule and work with suppliers to perform service, installation, calibration, maintenance activities for facility, utilities, and equipment. Troubleshoot manufacturing issues to identify root causes and implement corrective actions.

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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Charlotte, North Carolina, USA

Full-time

Roles & Responsibilities: t least a bachelor's degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or closely related field is required. Develop and execute validation plans, protocols, and test scripts for equipment, processes, and systems. Collaborate with cross-functional teams to establish validation strategies. Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Conduct testing

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

Instrument Validation Engineer - Lab ITJob Title - Instrument Validation Engineer - Lab IT

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Chicago, Illinois, USA

Full-time

Roles & Responsibilities: Bachelor's degree in engineering, Life Sciences, Computer Science, or a related field. Minimum of 3-5 years of experience in validation within the pharmaceutical, biotech, or medical device industries. Develop and execute validation protocols (IQ, OQ, PQ) for the migration of lab instruments from Windows 7 to Windows 10. Conduct thorough assessments of existing lab instruments to identify compatibility issues and ensure all instruments are supported on Windows 10. Ensur

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

Senior Validation EngineerJob Title - Senior Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Jacksonville, Florida, USA

Full-time

Responsibilities: Designing validation plans. Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes. Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits. Designing and executing engineering studies for critical process p

Validation EngineerJob Title - Validation Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Dallas, Texas, USA

Full-time

Responsibilities: Develop, execute, and document test method validation protocols to ensure accuracy, precision, and reliability of testing procedures. Lead validation activities for new or existing test methods, ensuring compliance with regulatory standards (e.g., FDA, ISO). Review and assess the performance of test methods, providing recommendations for improvements as needed. Perform data analysis and generate reports for test method validation studies, ensuring all required documentation is

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

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