Junior Validation Engineer

Junior Validation Engineer

Location: North Chicago, IL

Contract: 3+ month duration with potential for extensions

Work Location: On\-site, 1st shift, five days a week

Automated Systems, Inc. is seeking a Junior Validation Engineer with a minimum of 2 years of experience to support the decommissioning phase of an Expansion Project with one of our global pharmaceutical manufacturing clients located in North Chicago, IL.

Key Job Responsibilities

·       Authoring and execution of Decommissioning Documents

·       Assessment of assets to be decommissioned to determine appropriate change control according to global and site SOPs to document the decommissioning (i.e., Decommissioning Protocol or Engineering Change Management)

·       Perform "Technical Review" of decommissioning documentation

·       Issue / Deviation resolution as needed

·       Manage and route all documentation requiring review, pre\-approval and post\-approval in the Document Management System (e.g. KNEAT, OneVault, OneTrack)

·       Attend and participate in Project Validation Review Board Meetings on an as needed basis

·       Coordinate with Operations, Engineering, SMEs, etc. to drive completion of successfully deliverables

·       Provide direct supervisor with "Weekly Activity Report" (Planned vs Actual Activities; Summary of Risks / Roadblocks, Billable Hours)

Requirements

Education, Experience & Skill Requirements: 

• A Bachelor’s of Science Degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or Science is required. 
  


• At least 2+ years’ experience in FDA/cGMP compliant environment.
  


• Strong interpersonal and collaboration skills.
  


• Possess excellent oral and written communication skills with a high attention to detail.
  


• Must exhibit a professional demeanor, enthusiasm, and ability to work independently with minimal supervision.
  


• Proficient in Microsoft Word and Excel, computer software. Some experience with statistical software.
  


• Direct experience with writing and executing validation protocols is preferred.
  


• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.