Senior Validation Engineer

4 weeks ago


Houston, Texas, United States Lonza Full time
About the Role

We are seeking a highly skilled Senior Process Validation Engineer to join our team in Houston, Texas. As a key member of our team, you will be responsible for planning, executing, and closing out Process Performance Qualification (PPQ) and Continued Process Verification (CPV) activities for Viral Vector and Cell Therapy processes.

Key Responsibilities
  • Manage and track readiness/execution status for PPQ/CPV activities and deliverables.
  • Responsible for Global Data Mart data verification, oversight, and generation of control charts and run charts for CPV reports.
  • Generate CPV reports at required reporting frequencies.
  • Serve as project lead for PPQ/CPV and point of contact between Client, Quality Control, Quality Assurance, Supply Chain, Manufacturing, Data Science, and/or Commercial Development Organization.
  • Work with other MSAT teams on complex problems of diverse scope.
  • Actively contribute to continuous improvement activities for applicable processes and deliverables.
  • Data Management, Generation of Process Validation/CPV documents.
  • Organize, manage, and interpret data, perform detailed data analysis.
  • Generate PPQ/PV and/or CPV documents (plans, protocols, reports) according to timelines and commitments/Quality Agreements.
Requirements
  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, or other Life Sciences Degree.
  • 5+ years of experience/SME level of understanding with manufacturing/aseptic processes, process validation, Process Performance Qualification (PPQ), and Continued Process Verification (CPV).
  • Extensive experience within cGMP regulated production environment.
  • CGT (Cell and Gene Therapy) experience preferred.
  • Experience working with quality systems.
  • Ability to interface and communicate directly with clients.
  • Strong technical writing skills.


  • Houston, Texas, United States Lonza Full time

    Job Title: Senior Process Validation EngineerLonza is a global leader in life sciences, operating across three continents. We're seeking a Senior Process Validation Engineer to join our team in Houston, Texas.Responsibilities:Develop and execute process validation plans, protocols, and reports for Viral Vector and Cell Therapy processes.Manage and track...


  • Houston, Texas, United States Lonza Full time

    Job Title: Senior Process Validation EngineerLonza is a global leader in life sciences, operating across three continents. We're seeking a Senior Process Validation Engineer to join our team in Houston, Texas.Job Summary:The Senior Process Validation Engineer will be responsible for planning, executing, and closing out Process Performance Qualification (PPQ)...


  • Houston, Texas, United States Lonza Full time

    About the RoleWe are seeking a highly skilled Senior Process Validation Engineer to join our team at Lonza. As a key member of our team, you will be responsible for ensuring the quality and compliance of our biologics and cell therapy products.Key ResponsibilitiesDevelop and execute process validation plans to ensure compliance with regulatory...


  • Houston, Texas, United States Lonza Full time

    About the RoleWe are seeking a highly skilled Senior Process Validation Engineer to join our team in Houston, Texas. As a key member of our team, you will be responsible for planning, executing, and closing out Process Performance Qualification (PPQ) and Continued Process Verification (CPV) activities for Viral Vector and Cell Therapy...


  • Houston, Texas, United States Lonza Full time

    About the RoleWe are seeking a highly skilled Senior Process Validation Engineer to join our team in Houston, Texas. As a key member of our team, you will be responsible for planning, executing, and closing out Process Performance Qualification (PPQ) and Continued Process Verification (CPV) activities for Viral Vector and Cell Therapy processes.Key...


  • Houston, Texas, United States Lonza Full time

    About the RoleWe are seeking a highly skilled Senior Process Validation Engineer to join our team in Houston, Texas. As a key member of our team, you will be responsible for planning, executing, and closing out Process Performance Qualification (PPQ) and Continued Process Verification (CPV) activities for Viral Vector and Cell Therapy processes.Key...


  • Houston, Texas, United States Engineer Up Full time

    Job DescriptionWe are seeking a skilled Senior Frontend Developer to join our team at Engineer Up. As a key member of our development team, you will be responsible for designing and implementing high-quality user interface components using React.Key Responsibilities:Developing reusable components and front-end libraries for future useTranslating designs and...


  • Houston, Texas, United States Engineer Up Full time

    About Engineer UpWe are a mission-driven company that partners with Fortune 500 companies to deliver customized IT consulting services. Our goal is to disrupt how good, hard-working people advance their careers in tech.Job DescriptionWe are seeking a skilled JavaScript developer to join our team. As a React.js specialist, you will be responsible for...


  • Houston, Texas, United States Engineer Up Full time

    Job DescriptionWe are seeking a skilled Senior Frontend Developer to join our team at Engineer Up. As a key member of our development team, you will be responsible for designing and implementing high-quality user interface components using React.Your primary focus will be on developing reusable components and front-end libraries for future use, while...


  • Houston, Texas, United States Immatics NV Full time

    Job Title: Validation Engineer IIAt Immatics NV, we are seeking a highly skilled Validation Engineer II to join our team in the Facilities Engineering & Technical Operations department. As a key member of our team, you will be responsible for creating and executing validation documents used to qualify equipment for pharmaceutical manufacturing and testing...

  • Senior Engineer

    3 weeks ago


    Houston, Texas, United States Sullivan Process Controls LLC Full time

    Job Title: Senior EngineerWe are seeking a highly skilled Senior Engineer to join our team at Sullivan Process Controls LLC. As a Senior Engineer, you will be responsible for designing, creating Bills of Materials (BOMs), and drawings that meet our customer's requirements.Key Responsibilities:Collaborate with our sales team to present our technical expertise...


  • Houston, Texas, United States Powell Industries Full time

    Senior Electrical EngineerPowell Industries, a leading manufacturer of electrical equipment, is seeking a highly motivated Senior Electrical Engineer to join our Research and Development Department. As part of our expansion of New Product Development, we are looking for a talented engineer to contribute to the design and development of innovative electrical...


  • Houston, Texas, United States JE Dunn Construction Full time

    Job Title: Senior M/E EngineerJE Dunn Construction is seeking a highly skilled Senior M/E Engineer to join our team. As a Senior M/E Engineer, you will be responsible for leading complex mechanical, electrical, and field construction activities.Key Responsibilities:Develop and implement mechanical and electrical scopes of work for select projects.Provide...


  • Houston, Texas, United States KBR Full time

    Job Title: Senior Electrical EngineerKBR is seeking a highly skilled Senior Electrical Engineer to join our team. As a Senior Electrical Engineer, you will be responsible for designing, developing, and testing electrical systems for various projects.Key Responsibilities:Design and develop electrical systems, including circuit diagrams, wiring diagrams, and...

  • Senior Riser Engineer

    3 weeks ago


    Houston, Texas, United States tsu Full time

    Job Title: Senior Riser EngineerWe are seeking a highly skilled Senior Riser Engineer to join our team in Houston, Texas. As a key member of our engineering team, you will be responsible for providing deepwater riser engineering expertise in various types of deepwater risers.Key Responsibilities:Prepare detailed deepwater riser calculations and perform...


  • Houston, Texas, United States Town of Prosper, TX Full time

    Job Title:Senior Traffic EngineerJob Summary:The Town of Prosper, TX is seeking a highly skilled Senior Traffic Engineer to join our team. As a key member of our Engineering Services Department, you will be responsible for providing high-level traffic engineering support to our Director and various divisions. Your expertise will be crucial in planning,...


  • Houston, Texas, United States ARES Full time

    Job Title: Senior Systems EngineerWe are seeking a highly skilled Senior Systems Engineer to join our team at ARES. As a key member of our engineering team, you will be responsible for leading systems engineering initiatives and collaborating with cross-functional teams to deliver complex systems.Key Responsibilities:Apply systems engineering principles and...


  • Houston, Texas, United States Barrios Full time

    Job Title: Senior Systems EngineerWe are seeking a highly skilled Senior Systems Engineer to join our team at Barrios Technology. As a key member of our engineering team, you will be responsible for leading the development of systems engineering products for the NASA Extravehicular Activity (EVA) and Human Surface Mobility (HSM) Program.Responsibilities:Work...


  • Houston, Texas, United States Barrios Full time

    Job Title: Senior Systems EngineerWe are seeking a highly skilled Senior Systems Engineer to join our team at Barrios Technology. As a key member of our engineering team, you will be responsible for leading the development of systems engineering products for the NASA Extravehicular Activity (EVA) and Human Surface Mobility (HSM) Program.Responsibilities:Work...


  • Houston, Texas, United States Apex Systems Full time

    Senior Hardware/Firmware Debug EngineerApex Systems is seeking a highly skilled Senior Hardware/Firmware Debug Engineer to join our client, a global leader in IT innovation. This is a full-time, direct hire role with the client, offering relocation assistance.Key Responsibilities:Lead multiple project teams of electrical hardware engineers and...