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Commissioning, Qualification, and Validation (CQV) Consultant (REF10449T)

Company: ProPharma Group
Location: Irvine
Posted on: November 22, 2022

Job Description:

Company Description
ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
Job Description

  • Perform all job functions of Validation Engineer
  • Develop Installation, Operational and Performance qualification documents. Preparing and executing validation documents for multiple systems
  • Execute protocols including complex systems such as process validation, complex utilities, complex manufacturing equipment, formulation systems and basic knowledge of laboratory validation (not required but preferred).
  • Will work in one or more validation subjects; such as laboratory equipment, temperature mapping, facilities utilities, process equipment, packaging equipment, cleaning, computers, HVAC or controls.
  • Monitor and report on the execution of multiple validation tasks.
  • Understanding the hours budgeted for completion of each task on a specific project.
  • Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.
  • Interpretation of 21 CFR Part 11, 210, 211, and 820 as well as understanding of FDA cGMPs, FDA Guidelines and European Guidelines (where applicable).
  • Travel is required.
  • Other duties as assigned.
    Qualifications
    • B.S./B.A. in Engineering or Science or related field as a minimum. 4 years of relevant work experience in lieu of education requirement.
    • Minimum 2-3 years of experience in the field of validation or 4+ years of experience in related industry.
    • Candidates must have excellent verbal communication and technical writing skills.
    • Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred)
    • Familiarity with more than one area of validation is expected.
    • Ability to work with multiple individuals (where applicable); ability to execute multiple tasks associated within the validation field.
    • Ability to monitor and report on the execution of multiple validation tasks on a routine basis.
    • Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
    • Ability to read, prepare and analyze data for development of reports, ability to read and assemble summary documents as required.
    • Proficient in Microsoft Word, Excel, Power Point and Project.
    • Must be willing to travel regionally and/or nationally throughout the US.
      Additional Information
      We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
      ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Keywords: ProPharma Group, Irvine , Commissioning, Qualification, and Validation (CQV) Consultant (REF10449T), Professions , Irvine, California

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