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Quality Assurance Validation Engineer

Your Role:  

The Validation Engineer is responsible for the design, schedule, execution, and evaluation of scientifically and statistically sound qualification experiments which define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes and Utilities function in a consistent and repeatable manner, and are in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.

The Validation Engineer schedules activities involving manufacturing equipment to maximize equipment utilization, prepares detailed, concise documentation dossiers on completed studies that summarize the experimental results, specifications, and conformance to defined acceptance criteria, provides technical support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs as needed.

 

Responsibilities:

  • You will be coordinating multiple projects, documenting activities via protocols and summary report templates. Researches governmental regulatory requirements on each assigned project to ensure that each study subject is challenged to meet required specifications
  • Prepares scientifically sound Validation Study Protocols that incorporate the defined specifications into acceptance criteria and assessment procedures
  • Schedules the execution of Validation studies with the appropriate department
  • Prepares detailed, concise documentation dossiers on completed studies that summarize the studies experimental results and specifications and their conformance to defined acceptance criteria
  • This role coordinates and provides support and expertise to multiple projects
  • When the facility undergoes changes, this role will provide input on re-validation, assessing risks, developing and/or reviewing validation requirements and design deliverables.
  • This individual will assess risks involved in processing steps as well as risks related to equipment

 

Basic Qualifications

  • Minimum of 5+ years experience in GMP environment 
  • Bachelor's degree in a science or engineering related field

Preferred Qualifications

  • Experience with contractor manufacturing and cGMP API environment highly
Job Requisition ID:  187435
Location:  Madison
Career Level:  D - Professional (4-9 years)
Working time model:  full-time


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