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Validation Consultant - temperature mapping experience

Location: Irvine
Posted on: September 12, 2018

Job Description:

Reporting to the Regional Manager, Southern California, the Engineer I will work in the areas of upstream or downstream processes, supporting biopharmaceutical clients in the region. Responsibilities

  • Review analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data
  • Investigate deviations, write investigation reports and create summary reports.
  • Promote cGMP and regulatory compliance into assigned projects
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
  • Update Hyde formatted resume in huddle as new skills are acquired or projects are completed
  • Monthly check in with Site Lead or Regional Manager to discuss project deliverables.
  • Adhere to all laboratory policies and procedures.
  • Adhere to all corporate and laboratory safety policies.
  • Troubleshoot process and equipment issues.
  • Develop and maintain internal quality systems and procedures. Qualifications
    • BS in Science or Engineering or related discipline
    • 0-3 years of biopharmaceutical industry experience in validation, quality systems, operations, engineering or any combination thereof
    • Strong verbal and written communication skills, including presentation of data.
    • The ability to work with multiple clients and projects concurrently.
    • The ability to execute according to assigned project priority in order to meet project timelines.
    • The ability to perform individually and in teams.
    • Strong computer knowledge including Microsoft Office products.
    • Familiarity with basic statistics and statistical analysis packages.
    • At minimum, theoretical knowledge of FDA/ICH guidelines, applicable regulations, and standards routinely used in the pharmaceutical industry.
    • Ability to relate with people at all levels within an organization, including diverse cultures
    • Willingness to travel as needed Since 1993, Hyde E+C has worked as an integral part of project teams for clients and equipment vendors in the pharmaceutical and biopharmaceutical industries, resulting in the successful construction, commissioning and validation of facilities and equipment. As a member of the Hyde team, you will be responsible for providing state-of-the-art custom solutions to leaders in our industry. As we continue to grow our operations globally, we strive to hire the best talent-men and women dedicated to quality and innovation. We offer a collaborative culture, challenging projects, and excellent compensation and benefits. You will find the following values reflected in our company:
      • Family
      • Integrity
      • Respect
      • Wisdom
      • Adventure You must be authorized to work in the United States. Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.

        Keywords: HYDE ENGINEERING + CONSULTING, Irvine , Validation Consultant - temperature mapping experience, Professions , Irvine, California

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