Senior Validation Scientist

hace 1 semana

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Summary:

We are seeking a highly skilled and experienced Senior Validation Scientist to provide technical validation engineering support for process and/or equipment upgrades, replacements, and modifications within laboratory, manufacturing, or manufacturing support environments. The ideal candidate will have advanced validation knowledge, strong problem-solving skills, and experience leading projects in a regulated industry.

Responsibilities:

  • Troubleshoot systemic validation issues and apply advanced validation engineering principles to major system or process modifications and capital projects.
  • Develop, organize, and analyze results for complex validation engineering projects, ensuring successful execution of validation protocols and reports.
  • Develop and improve validation engineering techniques, policies, and procedures.
  • Supervise and guide a small team of engineers and technicians, providing oversight for ongoing and project-based work.
  • Provide technical solutions to complex validation problems using ingenuity and creativity.
  • Work closely with manufacturing, process development, utilities, facilities, labs, and quality assurance to develop requirements and recommendations for large-scale process and system modifications.
  • Manage the validation responsibilities of engineering projects, ensuring they are completed on schedule, within budget, and in compliance with quality standards.
  • Develop departmental or project budgets, encompassing multiple disciplines.
  • Ensure prompt and regular attendance to the workplace.

Skills:

  • Expertise in equipment qualification, cleaning, and sterilization processes.
  • Ability to provide innovative, thorough, and practical solutions to difficult technical problems.
  • Lead efforts of a group of peers, supervise staff or project resources, and ensure the successful completion of major programs.
  • Represent the organization as the primary technical contact on contracts and projects, coordinating with senior external personnel.
  • Understand regulatory trends in the industry and apply them to organizational direction, with experience interacting with FDA or equivalent regulatory bodies.
  • Ability to handle multiple projects simultaneously, with a focus on schedule development, collaboration, and cost management.
  • In-depth knowledge of validation processes and requirements.
  • Ability to manage projects, delegate work, and oversee contractors and vendors.
  • Effective interaction with diverse communication styles and ability to collaborate and facilitate cross-functional teams.
  • Strong problem-solving skills and the ability to make decisions based on scientific and engineering principles.

Requirements

  • Education/Experience:
    • Doctorate degree or Master's degree with 3 years of directly related experience, or
    • Bachelor's degree with 5 years of directly related experience, or
    • Associate's degree with 10 years of directly related experience, or
    • High school diploma/GED with 12 years of directly related experience.
  • Preferred Experience:
    • Experience in URS, DS, and Equipment Risk Assessments.
    • Experience in characterization and validation, including the development and execution of protocols and reports.
    • Hands-on experience in device assembly equipment and packaging equipment validation.

  • Senior Validation Scientist

    hace 1 mes

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

    Job Summary: We are seeking a highly skilled and experienced Senior Validation Scientist to join our team at Validation & Engineering Group, Inc. The ideal candidate will have a strong background in validation and engineering, with expertise in aseptic process validation, equipment qualification, and cleaning and sterilization. Key Responsibilities:Develop...

  • Senior Validation Professional

    hace 1 mes

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

    Job Title: Sr Validation ScientistCompany: Validation & Engineering Group, Inc.Validation & Engineering Group, Inc. is a leading services provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. Our services encompass Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and...

  • Senior Process Development Scientist

    hace 1 mes

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

    Job Title: Senior Process Development ScientistIntegrated Services For Productivity & Validation, Inc is seeking a highly skilled Senior Process Development Scientist to join our team. As a key member of our process development team, you will be responsible for developing and implementing technical solutions to improve manufacturing processes and product...

  • Senior Process Development Scientist

    hace 1 mes

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

    Job Title: Senior Process Development ScientistJob Summary:Integrated Services For Productivity & Validation, Inc is seeking a highly skilled Senior Process Development Scientist to join our team. As a key member of our process development team, you will be responsible for developing and implementing technical solutions to drive business growth and improve...

  • Senior Process Development Scientist

    hace 1 mes

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

    Job SummaryIntegrated Services For Productivity & Validation, Inc is seeking a highly skilled Senior Process Development Scientist to join our team. The ideal candidate will have a strong background in automatic visual inspection machines, technical report preparation, and business/scientific presentations.Key ResponsibilitiesProvide technical guidance to...

  • Senior Validation Specialist

    hace 1 mes

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

    Job Summary: We are seeking a highly skilled Sr Validation Scientist to join our team at Validation & Engineering Group, Inc. The ideal candidate will have a strong background in validation engineering, with experience in regulated environments such as pharmaceutical, biotechnology, and medical devices. Key Responsibilities:Develop and implement validation...

  • Sr Validation Scientist

    hace 4 semanas

    Juncos, Puerto Rico QRC Group, LLC A tiempo completo

    Sr. Validation Scientist with experience working with Analytical Instruments and knowledge in validation, equipment qualification, cleaning and sterilization. RequirementsDoctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of...

  • Sr Validation Scientist

    hace 2 semanas

    Juncos, Puerto Rico QRC Group, LLC A tiempo completo

    Sr. Validation Scientist with experience working with Analytical Instruments and knowledge in validation, equipment qualification, cleaning and sterilization. RequirementsDoctorate degree or Master's degree and 3 years of directly related experience orBachelor's degree and 5 years of directly related experience orAssociate's degree and 10 years of directly...

  • Senior Scientist

    hace 1 mes

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

    Job Summary: We are seeking a highly skilled Senior Scientist to join our Process Development team. The ideal candidate will have a strong background in scientific research and development, with a focus on process development and implementation. Key Responsibilities: Conceive, design, and implement scientific experiments to advance process development ...

  • Sr Validation Scientist

    hace 2 semanas

    Juncos, Puerto Rico QRC Group, LLC A tiempo completo

    Job DescriptionSr. Validation Scientist with experience working with Analytical Instruments and knowledge in validation, equipment qualification, cleaning and sterilization. RequirementsDoctorate degree or Master's degree and 3 years of directly related experience orBachelor's degree and 5 years of directly related experience orAssociate's degree and 10...

  • Sr. Validation Scientist

    hace 4 semanas

    Juncos, Puerto Rico QRC Group, Inc A tiempo completo

    Job DescriptionSr. Validation Scientist with experience working with Analytical Instruments and knowledge in validation, equipment qualification, cleaning and sterilization. QualificationsDoctorate degree or Master's degree and 3 years of directly related experience orBachelor's degree and 5 years of directly related experience orAssociate's degree and 10...

  • Sr Validation Scientist

    hace 4 semanas

    Juncos, Puerto Rico QRC Group, LLC A tiempo completo

    Job DescriptionSr. Validation Scientist with experience working with Analytical Instruments and knowledge in validation, equipment qualification, cleaning and sterilization. RequirementsDoctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10...

  • Sr. Validation Scientist

    hace 3 semanas

    Juncos, Puerto Rico QRC Group, Inc A tiempo completo

    Job DescriptionSr. Validation Scientist with experience working with Analytical Instruments and knowledge in validation, equipment qualification, cleaning and sterilization. QualificationsDoctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience orAssociate's degree and 10...

  • Senior Validation Specialist

    hace 1 mes

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

    Job Summary: We are seeking a highly skilled Sr Validation Scientist to join our team at Validation & Engineering Group, Inc. As a key member of our Validation & Engineering Group, you will be responsible for ensuring the highest standards of quality and compliance in our clients' products and processes.About the Role: In this role, you will have the...

  • Process Development Scientist

    hace 1 mes

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

    Job Title: Process Development ScientistAbout the Role:Validation & Engineering Group, Inc. is seeking a talented Process Development Scientist to join our team. As a key member of our Validation & Engineering Group, you will be responsible for developing and executing processes and equipment characterization protocols. Your expertise will be essential in...

  • Senior Process Development Scientist

    hace 1 mes

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

    Job Summary: We are seeking a highly skilled and dedicated individual to join our team as a Senior Process Development Scientist.About the Role: As a Senior Process Development Scientist, you will be responsible for independently conceiving, designing, implementing, and advancing scientific experiments that contribute to the successful completion of goals...

  • 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...

  • Process Development Scientist Position at Validation

    hace 3 semanas

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

    Company OverviewValidation & Engineering Group, Inc. (V&EG) is a leading services supplier that provides solutions for various industries, including Pharmaceuticals, Biotechnology, Chemicals, Food, and Medical Devices. Our expertise spans Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.Job DescriptionWe are...

  • Senior Validation Specialist

    hace 1 semana

    Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

    Job SummaryWe are seeking a highly skilled and experienced Senior Validation Scientist to provide technical validation engineering support for process and/or equipment upgrades, replacements, and modifications within laboratory, manufacturing, or manufacturing support environments.About the RoleTroubleshoot systemic validation issues and apply advanced...

  • Sr. Validation Scientist

    hace 1 semana

    Juncos, Puerto Rico Kelly Services, Inc. A tiempo completo

    At Kelly® Science, Engineering, Technology & Telecom (SETT), we’re passionate about helping you find a job that works for you. How about this one?We’re seeking a Sr. Validation Scientist to work with one of out top biotechnology industry client at the East area of PR. With us, it’s all about finding the job that’s just right. Pay rate: ...