Lead Characterization and Validation Engineer

hace 2 semanas


Juncos, Puerto Rico QRC Group, Inc A tiempo completo

We are seeking a Lead Characterization and Validation Engineer at QRC Group, Inc.

About the Role

As a key member of our team, you will be responsible for leading Characterization and Validation efforts in a regulated industry. This role involves performing risk assessments, developing protocols, executing tests, and creating reports to ensure the quality of our products.

Responsibilities
  • Conduct URS, DS, and equipment risk assessments to identify potential hazards and develop strategies for mitigation.
  • Create and execute Characterization and Validation protocols to verify product performance and compliance with regulatory requirements.
  • Analyze data from characterization and validation activities to inform engineering decisions and optimize product design.
  • Develop and maintain technical documentation, including Characterization and Validation reports, to support regulatory submissions and internal decision-making processes.
Requirements
  • A Doctorate degree or Master's degree with 3 years of experience in Engineering, or a Bachelor's degree in Engineering with 5 years of experience (Mechanical Engineering, Industrial Engineering, Chemical Engineering, or Electrical Engineering).
  • Bilingual proficiency in Spanish and English (write and speak).
  • Strong technical writing skills to communicate complex information effectively.
  • Proficiency in computer-aided design tools and software applications.
Additional Information

All candidate information will be kept confidential in accordance with EEO guidelines.

The estimated salary range for this position is between $100,000 and $150,000 annually, based on location and industry standards.



  • Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    About Integrated Services For Productivity & Validation, IncWe are a dynamic company seeking an experienced Senior Validation Engineer to join our team. In this role, you will be responsible for developing and executing characterization and validation protocols for our equipment.


  • Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Job OverviewWe are seeking a highly skilled Senior Characterization and Validation Professional to join our team at Integrated Services For Productivity & Validation, Inc.Estimated SalaryThe estimated salary for this position is $120,000 - $180,000 per year, based on industry standards and location.Job DescriptionAs a Senior Characterization and Validation...


  • Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Integrated Services For Productivity & Validation, Inc is a leading organization in the field of combination products and medical devices. We are seeking a highly skilled Senior Scientific Research Lead or Senior Validation Engineer to join our team.Job SummaryThe ideal candidate will have expertise in characterization and validation, with experience in...


  • Juncos, Puerto Rico Qrc Group, Inc A tiempo completo

    About QRC Group, LLCQRC Group, LLC is a firm dedicated to providing services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.We offer our expertise through our website where you can learn more about our services and solutions.Job SummaryA Sr. Engineer with experience in regulated industry performing...


  • Juncos, Puerto Rico Qrc Group, Llc A tiempo completo

    Company OverviewQrc Group, LLC is a leading manufacturer of innovative products in the medical devices industry.SalaryThe estimated annual salary for this position is $110,000 - $140,000, depending on experience.Job DescriptionWe are seeking an experienced Senior Development Engineer to join our team. As a key member of our process development team, you will...


  • Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

    Job Summary:Validation & Engineering Group, Inc. is seeking a highly skilled Senior Process Validation Engineer to join our team. As a key member of our Validation & Engineering Group, you will be responsible for providing and/or directing the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations,...


  • Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

    Job Title:Sr. Validation EngineerAbout the Role:We are seeking a talented Sr. Validation Engineer to join our team at Validation & Engineering Group, Inc., a leading services supplier in the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries.In this role, you will be responsible for independently providing and/or directing the...

  • Senior Validation Expert

    hace 20 horas


    Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Job SummaryWe are seeking a highly skilled Senior Validation Expert to join our team at Integrated Services For Productivity & Validation, Inc. This is a fantastic opportunity for experienced professionals to take on new challenges and contribute to the success of our company.About UsAt Integrated Services For Productivity & Validation, Inc, we pride...

  • Senior Engineer

    hace 1 mes


    Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

    Job SummaryValidation & Engineering Group, Inc. is seeking a highly skilled Senior Engineer to join our team. As a key member of our Validation & Engineering Group, you will be responsible for providing technical leadership and expertise in process optimization, validation, and compliance.Key ResponsibilitiesDevelop and implement process optimization...

  • Senior Technical Lead

    hace 1 semana


    Juncos, Puerto Rico Mirus Consulting Group A tiempo completo

    About Mirus Consulting GroupMirus Consulting Group is a local company based in Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations.Job OverviewThe Senior Technical Lead - Computer System Validation role requires a highly experienced professional with advanced...


  • Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

    Job Title: Sr. Validation EngineerAbout the RoleWe are seeking a highly skilled Sr. Validation Engineer to join our team at Validation & Engineering Group, Inc. This is an exciting opportunity for a professional with extensive knowledge of validation processes and requirements.Key ResponsibilitiesValidation Engineering: Apply advanced validation engineering...

  • Sr. Engineer

    hace 2 semanas


    Juncos, Puerto Rico QRC Group, Inc A tiempo completo

    Job DescriptionSr Engineer with experience in regulated industry performing Characterization and Validation.Tasks:URS, DS, and Equipment Risk AssessmentsDevelopment of Characterization and Validation protocolsExecution of Characterization and Validation protocolsDevelop Characterization and Validation reportsDevice assembly equipment and packaging equipment...


  • Juncos, Puerto Rico Qrc Group Llc A tiempo completo

    At Qrc Group Llc, we are seeking a highly skilled Sr Engineer to join our team.We offer a competitive salary of $120,000 - $180,000 per year, depending on experience.Job Description:Main Responsibilities:Perform Characterization and Validation in a regulated industry setting.Develop and execute protocols for equipment validation and device assembly.Create...

  • Validation Specialist

    hace 1 semana


    Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Job OverviewWe are seeking an experienced Validation Specialist to join our team at Integrated Services For Productivity & Validation, Inc. This role involves leveraging expertise in equipment and device validation to ensure the highest quality of products.Estimated Salary Range: $90,000 - $120,000 per year.About the JobThis is a challenging opportunity for...

  • Electrical Engineer

    hace 3 semanas


    Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    We are seeking an experienced Electrical Engineer to join our team at Integrated Services For Productivity & Validation, Inc. The ideal candidate will have a strong background in electrical engineering and be able to lead technical projects.As an Electrical Engineer - Technical Lead, you will be responsible for:Leading technical projects and ensuring they...

  • Senior Technical Lead

    hace 2 meses


    Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

    Job SummaryValidation & Engineering Group, Inc. is seeking a highly skilled Senior Engineer to join our team. The ideal candidate will have a strong background in engineering principles and practices, with experience in process optimization and troubleshooting. The successful candidate will be responsible for independently providing and/or directing the...

  • Research Scientist Leader

    hace 2 semanas


    Juncos, Puerto Rico Integrated Services For Productivity & Validation, Inc A tiempo completo

    Job SummaryWe are seeking a highly skilled Research Scientist Leader to join our team at Integrated Services For Productivity & Validation, Inc.About the RoleThis is an exceptional opportunity for a dedicated and experienced professional to lead our research initiatives and drive innovation in Combination Products or Medical Devices. The ideal candidate will...


  • Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

    About the PositionWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Validation & Engineering Group, Inc. This individual will be responsible for ensuring the highest quality standards in manufacturing and distribution processes.Job DescriptionThe successful candidate will have a strong background in quality assurance,...


  • Juncos, Puerto Rico Validation & Engineering Group, Inc A tiempo completo

    Job Summary:We are seeking a highly skilled Senior Validation Engineer to join our team at Validation & Engineering Group, Inc. The ideal candidate will have a strong background in validation engineering principles and practices, with experience in designing and implementing major system or process modifications and/or capital projects.Key...


  • Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

    About the RoleWe are seeking an experienced Process Optimization Engineer Lead to lead the characterization of process optimization strategies and troubleshoot operational issues in operations, manufacturing, pilot plant, or capital project environments.This role involves applying advanced engineering principles, designing and implementing system...