Medical Device Sterilization Specialist

Indianapolis, IN

Industry: Medical Device Job Number: 134587

 

Medical Device Sterilization and Environmental Controls

Environment:

Our client is a large medical device manufacturer. They are in need of a Sterilization Specialist with experience in Gamma Sterilization, and/or Environmental Monitoring as it pertains to the manufacturing of Medical Devices.

Duties/Responsibilities/Scope of Work

This individual will come from a Medical Device background, and must have strong, hands-on experience in  sterilization for Medical Device manufacturing. This individual will be supporting a large remediation so must be comfortable in a fast paced environment. This person will be joining a team that is responsible for helping to develop, conduct, control and monitor production processes to ensure that their device confirms to its specifications, including the monitoring and control of process parameters and device characteristics during production, as required by 21 CFR 820.70(a). Help with the establishment of procedures to adequately control environmental conditions, as required by 21 CFR 820.70(c). There are a large number of NCR’ s that were identified with a failure to properly investigate. This person may be tasked with looking at the clients SOP’ s as it pertains to NCR’ s and the procedures to ensure investigations into excursions are investigated and documented properly. Based on the candidates experience they may be asked to help in a number of different area’ s.

Ideally this person should have an understanding of  Gamma Sterilization regulations and be able to come in and help make sure proper environmental controls are in place. Not looking for a Director Level consultant, this is a very hands on role with a focus on documentation.

Required Experience:
  • Medical Device 
  • Sterilization for Medical Device (EO and Gamma)
  • Writing Sterilization Testing Rationale
  • Technical Writing of SOP’ s and Work Instructions
  • Remediation Experience

Job Type: Contract 

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