Previous Job
Ref No.: 18-65897
Location: Plymouth, Minnesota
Position Type:Full Time/Contract
Start Date: 09/10/2018
Microbiologist Engineer
Plymouth, MN
Fulltime Permanent

Job Description:
A Microbiologist Engineer who can review the data regarding device validation, sterilization results (from technical perspective) and assess devices for sterility, cleaning and prepare / review the protocols and reports.
Will have responsibility for defining and overseeing environmental and sterilization process controls to assure that medical devices consistently comply with FDA, ISO and QS requirements.
Reviews sterile load cycle data and performs sterile load release for finished product lots manufactured at host facility or contract manufacturers.
Administers the Environmental Monitoring Program for the manufacturing areas including viable and non-viable particulate counts, product bio-burden, water and surface microbial levels, etc. to ensure an appropriately
controlled environment meeting regulatory expectations and industry standards.
Communicates detailed information regarding monitoring results and trends to Manufacturing and Quality; recommends revisions to monitoring program and/or manufacturing process controls and ensures effective corrective actions are implemented, where necessary.
Reviews and approves personnel hygiene and plant cleaning and pest/vermin control practices. Provides microbiological technical expertise to the Facilities department regarding cleaning and contamination control.
Provides microbial technical expertise during new product development activities, process modification studies and failure investigations regarding microbiological contamination control.
Coordinates the biocompatibility testing of new products and materials ensuring that all required test results are reviewed and reports approved to meet project deadlines.
Reviews Change Order (DCO) notifications for impact to sterilization/microbial testing and establishes the change qualification approach where necessary.
Provides microbiological technical expertise to the Purchasing department in the selection and certification of component vendors.
Provides training when necessary to employees regarding product microbial and particulate contamination control.

Muqtadir Ali
Account Manager

Phone: 408-520-2535

IDC Technologies.