Process Validation Engineer

Location: West Chester, PA
Department: Azzur IT, LLC

Job Description

We at Azzur Group are looking for an  Process Validation Engineer to join our Azzur Consulting: Philadelphia team. 

  • Supports all Process Validation activities.
  • Author and execute process validation protocols.
  • Collaborate with various manufacturing groups to determine validation requirements.
  • Perform statistical analysis and analyzes results.
  • Coordinates and schedules technology transfer, validation, and production related activities.
  • Management of the identification, collection, distribution, analysis, and result compilation of process samples associated with validation and production activities.
  • Compilation and verification of process data used in technical reports and regulatory submissions.
  • Maintenance of collaboration and productivity software tools used to facilitate technology transfer, validation, and production planning.
  • Technical expertise for upstream and downstream operations for daily monitoring, troubleshooting and investigations.
  • Is responsible for the development and/or review of necessary PV documentation including Process Validation Master Plan, protocols, reports and related regulatory filing sections.
  • Scope will include upstream and downstream processes, protocol generation, execution, sample collection, deviation generation, and summary report with data analysis.

Qualifications:
  • Bachelor's degree in Engineering or related Scientific discipline.
  • 7+ years’ of process validation experience.
  • Ability to work for multiple clients throughout the region
  • Excellent written and verbal communication skills; excellent technical writing skills
  • Strong interpersonal skills and the ability to work in a team environment


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