Validation Engineer

Houston, TX, US • Posted 60+ days ago • Updated 1 day ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Collaboration
  • Manufacturing
  • Quality Assurance
  • Research and Development
  • Corrective And Preventive Action
  • Auditing
  • Biomedicine
  • Mechanical Engineering
  • Pharmaceutics
  • Good Manufacturing Practice
  • IQ
  • OQ
  • PQ
  • Mapping

Summary

Summary :
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.

Roles & Responsibilities:
  • Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities.
  • Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs).
  • Collaborate with Manufacturing, QA, Engineering, and R&D teams.
  • nalyze validation data, investigate deviations, and support CAPA implementation.
  • Prepare validation reports and support internal/external audits.
  • Review and support change controls for validated systems.

Education &Experience :
  • Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline).
  • 2-6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
  • Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820), and ICH guidelines.
  • Hands-on experience with IQ/OQ/PQ and Temperature Mapping of Controlled Temperature Units is required.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 3491c15739b65228d2dda717ca8d12ec
  • Posted 30+ days ago
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