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Validation Engineer

Company: Apex Systems
Location: Santa Rosa
Posted on: October 12, 2019

Job Description:

Job Description

Job #: 1001162

JOB DESCRIPTION

Responsibilities:


  • Author and revise validation plans, protocols, and SOP's
  • Oversee protocol execution while coordinating with Method Development, Validation, Production, QA and QC personnel
  • Summarize and evaluate protocol data, including resolution of discrepancies and exceptions
  • Work with Production department to assist in maintaining quality in production.
  • Review or re-qualify equipment, instruments, and facilities to maintain their validated state as defined by SOPs.
  • Present project results and recommendations to department management
  • Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise
  • Maintain and meet the highest standards in quality and regulatory compliance.
  • Follow, understand and comply with SOP's and policies on cGLP's and safety.
  • Perform any other duties as designated by the Manager, Technical and Instrumentation or dictated by the needs of the laboratory


    Qualifications


    • Bachelor's degree in engineering or life science and 4 years of experience in a GMP environment.
    • 8 + years of experience in pharmaceutical validation or equivalent industry experience preferred
    • Subject matter expert for the following areas: validation of software, automation, analytical instruments, or general equipment validation.
    • Experience with change management assessments for validated equipment, systems, and processes.
    • Experience with total method validations (TMVs) for LC-MS-MS instrumentation preferred


      Interested applicants can also email resumes to zgray@apexsystems.com for consideration.

      EEO Employer

      Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178-6178.

Keywords: Apex Systems, Santa Rosa , Validation Engineer, Engineering , Santa Rosa, California

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