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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

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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