Senior Validation Engineer

18 hours ago


Conshohocken, Pennsylvania, United States Gahagan & Bryant Associates Inc Full time
{"title": "Senior Validation Engineer", "description": "Job Summary

We are seeking an experienced Senior Validation Engineer to join our team at Gahagan & Bryant Associates Inc. The ideal candidate will have a strong background in CSV, automation, and validation principles, with expertise in sterile/aseptic facility CQV and thermal mapping experience.

Responsibilities
  • Support client commissioning/validation for facility, utility, equipment, cleaning, and process validation projects
  • Prepare and execute commissioning/validation lifecycle documents
  • Participate in clinical or commercial production, including green field construction, facility renovation, new product development, product launch, or product/process upgrade
  • Write summary reports for validation and qualification protocols
  • Support project milestones, priorities, and deadlines
  • Write operating procedures for technical equipment and practices and procedures
  • Perform system and process risk assessments and analyses
  • Schedule and coordinate protocol execution with other departments, including manufacturing, facilities, and project management
  • Develop project-specific validation plans and strategy
  • Manage and execute multiple projects to meet client priorities
  • Provide a practical approach to problem-solving
Requirements
  • Bachelor's degree in a related life sciences or engineering field
  • Years of GMP experience
  • Ability to converse about scientific matters
  • Candidate must have sterile/aseptic facility CQV experience
  • Thermal mapping experience is essential
  • Sterilization/SIP experience a plus
  • Ability to work independently or in collaboration with others
  • In-depth understanding and application of validation principles, concepts, practices, and standards
  • Considered a Subject Matter Expert (SME) in one area of validation
  • Proficient in current Good Manufacturing Practices and other applicable regulations
  • Experience with Sterile/Aseptic Filling
  • Experienced with all pertinent industry best practices, including development and execution of all applicable system life cycle deliverables
  • Demonstrated expertise in at least one aspect of system qualification and regulatory compliance
  • Excellent written communication skills with emphasis in technical writing
  • Proficient in Microsoft Word, Excel, PowerPoint, and Project
  • Must be willing to travel regionally and/or nationally throughout the U.S.
  • Candidate must be on-site during core hours M-F from 7am-3pm
", "lang_code": "en-US"}

  • Conshohocken, Pennsylvania, United States SPECTRAFORCE Full time

    Job Title: Senior Validation Engineering ProfessionalDuration: 14+ MonthsLocation: Conshohocken, PA 19428Job Summary:We are seeking a highly skilled Senior Validation Engineering Professional to join our team. As a key member of our commissioning and start-up services team, you will be responsible for ensuring that our clients' facilities, systems, and...


  • Conshohocken, Pennsylvania, United States Gahagan & Bryant Associates Inc Full time

    About the RoleGahagan & Bryant Associates Inc is seeking a highly experienced Senior Validation Engineer to join our Life Sciences division. As a key member of our team, you will be responsible for supporting client commissioning and validation for facility, utility, equipment, cleaning, and process validation projects.Key ResponsibilitiesCommissioning and...


  • Conshohocken, Pennsylvania, United States Compli Full time

    Job OverviewSenior Validation Engineer (Life Sciences)Compli is a comprehensive engineering contracting and consulting firm with a dedicated life sciences division focusing on pharmaceuticals, biotechnology, active pharmaceutical ingredients, medical devices, and laboratory facilities. We are in search of a seasoned Senior Validation Engineer to enhance our...


  • Conshohocken, Pennsylvania, United States Gahagan & Bryant Associates Inc Full time

    About the RoleGahagan & Bryant Associates Inc is seeking a highly experienced Senior Validation Engineer to join our Life Sciences division. As a key member of our team, you will be responsible for supporting client commissioning and validation for facility, utility, equipment, cleaning, and process validation projects.Key ResponsibilitiesCommissioning and...


  • Conshohocken, Pennsylvania, United States Intellectt Inc Full time

    Job Summary:We are seeking a highly skilled Sterile Process Expert to join our team at Intellectt Inc. as a Senior Validation Specialist. In this role, you will be responsible for conducting quality investigations, executing Commissioning, Qualification, and Validation (CQV) activities, and managing sterilization and steam-in-place (SIP) processes.Key...

  • Validation Expert

    1 week ago


    Conshohocken, Pennsylvania, United States Gahagan & Bryant Associates Inc Full time

    About the RoleGahagan & Bryant Associates Inc is seeking a highly experienced Senior Validation Engineer to join our Life Sciences division. As a key member of our team, you will be responsible for supporting client commissioning and validation projects, preparing and executing commissioning and validation lifecycle documents, and participating in various...


  • Conshohocken, Pennsylvania, United States Actalent Full time

    About the RoleWe are seeking a highly skilled Senior Civil Engineer to join our team at Actalent. As a key member of our engineering team, you will be responsible for supporting staff and project-level engineers in all aspects of projects, from conceptual planning to construction documentation.Key ResponsibilitiesReview local municipal ordinances and design...


  • Conshohocken, Pennsylvania, United States Colliers Engineering & Design Full time

    About the RoleWe are seeking a highly skilled Senior Track Design Engineer to join our team at Colliers Engineering & Design. As a key member of our rail engineering team, you will be responsible for applying engineering fundamentals to support project design teams.Key ResponsibilitiesPerform complex engineering calculations and create detailed...


  • Conshohocken, Pennsylvania, United States The Kendall Group Full time

    About The Kendall GroupThe Kendall Group is a leading provider of electrical, automation, and instrumentation solutions. Our company is comprised of seven divisions with 75+ locations in eleven states, serving a wide range of industries.Job SummaryWe are seeking a highly skilled Senior Relay Engineer to join our Relay & Power Systems team. As a key member of...


  • Conshohocken, Pennsylvania, United States PM Group Full time

    Senior Plumbing Engineer or DesignerWe are seeking a highly skilled Senior Plumbing Engineer or Designer to join our team at PM Group. As a key member of our engineering team, you will be responsible for delivering complex plumbing and fire protection systems for our clients in the life sciences industry.Key Responsibilities:Coordinate plumbing and fire...


  • Conshohocken, Pennsylvania, United States The Kendall Group Full time

    About The Kendall GroupThe Kendall Group is a leading provider of electrical and automation solutions, with a strong presence in the industrial and utility sectors. Our company is comprised of seven divisions, with over 75 locations across eleven states.Job SummaryWe are seeking a highly skilled and experienced Senior Relay Engineer to join our Relay & Power...


  • Conshohocken, Pennsylvania, United States Burns & McDonnell Full time

    Job SummaryWe are seeking a highly skilled Senior Underground Engineer to join our team at Burns & McDonnell. As a key member of our underground transmission and distribution team, you will be responsible for leading design teams, working closely with construction, procurement, and permitting teams, and developing new clients and relationships with existing...


  • Conshohocken, Pennsylvania, United States The Kendall Group Full time

    About The Kendall GroupThe Kendall Group is a leading provider of electrical, automation, and instrumentation solutions. Our company is comprised of seven divisions with 75+ locations in eleven states, serving a wide range of industries including electrical, automation, pipe, valve, and fittings products, steam, lighting, industrial controls, and...


  • Conshohocken, Pennsylvania, United States Finance of America Holdings LLC Full time

    Job OverviewRole Objective:The Senior Salesforce Engineer is instrumental in the development, testing, and implementation of Salesforce solutions. This position collaborates closely with product stakeholders and fellow developers to ensure a premium user experience that aligns with business requirements. The role emphasizes teamwork, innovative thinking...


  • Conshohocken, Pennsylvania, United States Cencora Full time

    About the RoleCencora is seeking a highly skilled and experienced Senior Software Engineer to join our team. As a key member of our development team, you will be responsible for designing, developing, and supporting our enterprise e-commerce B2B applications.This is a challenging and rewarding role that requires a strong understanding of software development...


  • Conshohocken, Pennsylvania, United States AECOM Full time

    Company OverviewTransforming Infrastructure for a Better TomorrowAECOM is at the forefront of creating sustainable infrastructure solutions that enhance the quality of life for communities worldwide. Our team of experts is dedicated to addressing the most intricate challenges in infrastructure, ensuring that our projects leave a lasting legacy for future...


  • Conshohocken, Pennsylvania, United States Senior Helpers - Havertown Full time

    Job Opportunity at Senior Helpers - HavertownJob Summary:We are seeking a compassionate and experienced Onsite Concierge Caregiver to join our team at Senior Helpers - Havertown. As a member of our team, you will provide personalized care and support to our clients in the comfort of their own homes.Key Responsibilities:Provide companionship and conversation...


  • Conshohocken, Pennsylvania, United States Burns & McDonnell Full time

    Position OverviewThe role entails providing expert engineering and consulting services for electrical substations, catering to clients both domestically and internationally. The primary focus will be on developing deliverables related to electrical protection & control and physical layout design. Projects will vary in scale, complexity, and voltage class,...


  • Conshohocken, Pennsylvania, United States Boomi L.P. Full time

    COMPANY:BoomiPOSITION:Senior Software Systems ArchitectJOB SUMMARY:As a Senior Software Systems Architect, you will play a pivotal role in enhancing the scalability and dependability of Boomi's operational systems. Your expertise will be crucial in automating the setup and upkeep of our infrastructure, ensuring that production incidents are promptly...


  • Conshohocken, Pennsylvania, United States Kelly Science, Engineering, Technology & Telecom Full time

    Senior Engineering SpecialistKelly Services is seeking a Senior Engineering Specialist for a prominent client.Position Overview:Facilitate the implementation of innovative strategies to ensure the safe and efficient delivery of high-quality products and services.Accountable for the advanced engineering design and initiation of GMP large molecule biologics...