Senior Validation Specialist

hace 4 días


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

The Senior Validation Specialist plays a crucial role in ensuring the compliance and quality of biotechnology processes and equipment. This position is responsible for leading validation projects, developing strategies, and collaborating with cross-functional teams to implement best practices and troubleshoot complex issues.

Key Responsibilities:
  • Lead validation projects, including IQ/OQ/PQ phases, and define validation strategies to ensure compliance and efficiency.
  • Oversight of process and equipment validation, including bioreactors, chromatography systems, autoclaves, and clean rooms, ensuring adherence to regulatory and operational standards.
  • Risk assessments to prioritize validation activities based on potential impact to product quality, patient safety, and regulatory compliance.
  • Development, review, and maintenance of validation documentation, including validation plans, protocols, reports, and traceability matrices.
  • Ensure compliance with regulatory guidelines, including FDA 21 CFR Part 11, GAMP 5, and ICH Q9, by staying up-to-date with regulatory trends and industry best practices.
Requirements:
  • Bachelor's degree in Life Sciences, Engineering, or related field; advanced degree preferred.
  • Minimum 5-7 years of experience in validation within the biotechnology or pharmaceutical industry, including hands-on experience with equipment, process, and computer system validation.
  • Expertise in GxP validation practices, including IQ/OQ/PQ for equipment, facilities, utilities, and computerized systems.
Compensation:

We offer an estimated salary of $80,000 - $110,000 per annum, depending on qualifications and experience. Additionally, we provide benefits such as health insurance, retirement plan, and opportunities for professional growth and development.



  • Juncos, Puerto Rico Quality Consulting Group A tiempo completo

    Job Title: Senior Validation SpecialistJob Summary: We are seeking a Senior Validation Specialist to join our team at Quality Consulting Group. As a key member of our validation team, you will be responsible for providing technical validation engineering support for process and equipment upgrades, replacements, and modifications.Develop and implement...


  • Juncos, Puerto Rico Mirus Consulting Group A tiempo completo

    Job DescriptionWe are seeking a highly skilled Senior Validation Specialist to join our team at Mirus Consulting Group in Humacao, Puerto Rico.About the RoleThis is an exciting opportunity for a senior quality assurance professional to lead our validation efforts and drive process improvements across our organization. As a key member of our team, you will be...


  • 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...


  • 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...


  • Juncos, Puerto Rico Qrc Group Llc A tiempo completo

    Qrc Group Llc is seeking a highly skilled Senior Instrument Validation Specialist to join their team. This role will play a key part in ensuring the quality and safety of instruments used in our facilities.The ideal candidate will have a Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of...


  • 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...


  • Juncos, Puerto Rico QRC Group, LLC A tiempo completo

    Job SummaryWe are seeking a highly skilled Senior Validation Specialist to join our team at QRC Group, LLC. The ideal candidate will have extensive experience working with analytical instruments and possess expertise in validation, equipment qualification, cleaning, and sterilization.About the RoleThis is a challenging and rewarding opportunity for a...


  • 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...


  • 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 Validation & Engineering Group, Inc A tiempo completo

    About the RoleValidation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries.We are seeking a highly skilled and dedicated individual to fill the position of Senior QA Compliance Specialist.About YouThis role requires a Quality Professional...


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

    Job SummaryWe are seeking a skilled Data Validation Specialist to join our team at Integrated Services For Productivity & Validation, Inc.About the RoleThe successful candidate will be responsible for ensuring the accuracy and reliability of data in various analytical instruments. This role requires strong expertise in analytical instruments and a solid...


  • 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...


  • 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 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...

  • Validation Specialist

    hace 4 semanas


    Juncos, Puerto Rico Mentor Technical Group A tiempo completo

    Job Title: Validation SpecialistMentor Technical Group is seeking a highly skilled Validation Specialist to join our team. As a Validation Specialist, you will be responsible for ensuring the quality and integrity of our products and services.Key Responsibilities:Perform validation activities according to project assignment, customer needs, and...


  • Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

    **About the Job**We are seeking a highly skilled Senior Validation Engineer to join our team at Flexible & Integrated Technical Services, LLC. This is a challenging and rewarding role that requires a strong background in validation engineering principles, experience in troubleshooting complex issues, and excellent project management...


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

    Job OverviewAt Validation & Engineering Group, Inc., we are seeking a highly skilled Scientific Validation Specialist to join our team. This position requires advanced engineering expertise and the ability to troubleshoot systemic validation issues.


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

    About the RoleWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Integrated Services For Productivity & Validation, Inc. In this critical role, you will be responsible for ensuring the quality of our products and services.As a Senior Quality Assurance Specialist, you will work closely with our operations team to identify...


  • Juncos, Puerto Rico QRC Group, LLC A tiempo completo

    We are seeking a highly skilled Senior Validation Specialist to join our team at QRC Group, LLC.The successful candidate will have experience working with Analytical Instruments and possess knowledge in validation, equipment qualification, cleaning and sterilization.RequirementsA minimum of a Doctorate degree or Master's degree with 3 years of directly...


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

    Job SummaryV&EG is seeking a highly skilled Senior Validation Expert to join our team in Juncos, Puerto Rico. The ideal candidate will have expertise in Cleanroom Operations, Parenteral Manufacturing, and Aseptic Process Simulation.About UsV&EG is a leading services provider for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices...