Validation Specialist with Sterilization Focus

6 days ago


Lakewood, New Jersey, United States MRINetwork Jobs Full time
Job Overview:

This position supports commercial and new R&D drug development activities in support of client projects involving all delivery systems manufactured in Lakewood, NJ plant.

The ideal candidate will have a strong background in pharmaceutical sciences, engineering, microbiology, or a similar degree, with a minimum of three years of relevant experience performing validation activities within an aseptic pharmaceutical environment.

Main Responsibilities:
  • Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of sterilization processes.
  • Participate or provide guidance for equipment sterilization programs during internal and external audits, including regulatory inspections, as needed.
  • Interface with customers on transfer discussions, timelines, project deliverables, etc.
Requirements:

Bachelors or master's degree in Pharmaceutical Sciences, Engineering, Microbiology, or a similar degree, and a minimum of three (3) years of relevant experience performing validation activities within an aseptic pharmaceutical environment.

Familiarity with current industry practices and guidelines, including those required/outlined by the FDA, ISO, EU, and ICH, and proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.



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