Sterility Engineer

Company Info
Comtec Information Systems
United States

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Sterility Engineer





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Job Description:

Position : Sterility Engineer
Location : Indianapolis, IN 
Relocation : Yes

The Sterility Engineer will create and coordinate execution of sterility assurance and aseptic process
validation protocols for our equipment and products. Integrates the microbiology process to drive
improvement in overall equipment effectiveness and operational excellence. Partners closely with Quality
and Engineering to train technicians on the sterility process to maintain our products and processes.
Key Responsibilities:
 The Sterility Engineer fully understands and executes the entire machine sterility process for all
Stork and West Aseptic equipment, including required utilities (steam, air, controls).
 Implement PM’s/CIL’s to prevent problems with SIP process or Loss of Sterility during production.
 Drives Root Cause Analysis on Loss of Sterility issues.
 Participates in CIP validations.
 Improves, modifies and upgrades processes to reduce costs and enhance quality to meet
customer satisfaction. Identifies methods to reduce variation in the processes.
 Ensures sterilization processes are in compliance with all government laws and regulations.
 Assists in improvement of Standard Operating Procedures for all sterilization processes. Ensures
and documents SOP’s compliance.
 Maintains effective communication with all persons involved with or affected by assigned
 Participates in solving problems with existing processes.
 Conducts food safety and defense self-inspections and reports on deficiencies.
 An understanding of mechanical equipment used in a manufacturing environment (Pumps,
motors, etc.).
 Ensures a safe working environment by following safety rules and helping improve the safety
 Incorporates new methods and processes to improve existing operations.
 Reviews product designs for manufacturability or completeness.
 Trains production personnel in new or existing methods.
 All other duties as assigned.
 Degree in Food Science or Microbiology, with experience in a food grade environment (FDA,
GMP’s, HACCP) with high speed packaging equipment preferred.
 Experience managing people and projects preferred
 Excellent organizational ability, the capability to manage multiple, dynamic cross functional
projects simultaneously