Validation Engineer

Watertown, MA
Science and Technology Operations – Manufacturing /
Full Time /
On-site

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Validation Engineer

  • How many years of experience do you have in a Qualification/Validation role in a technology or related field (i.e. pharmaceutical/medical device) manufacturing environment?
  • How many years of experience do you have in: Preparing qualification or validation studies of Facilities, Utilities, TCU’s, Analytical instruments, or Computerized systems?
  • How many years of experience do you have in: Maintaining and reviewing validation and compliance documentation?
  • How many years of experience do you have in: Using Kaye Validator, Ellab, Microsoft Word and Excel software?
  • How many years of experience do you have in: Working with regulatory requirements (FDA, EMA, ICH, etc.) and industry standards (GMP, GLP, GAMP, etc.) related to CQV?
  • How many years of experience do you have in: Working with risk assessment methodologies (e.g., FMEA) and root cause analysis?
  • Do you have working knowledge of cGMP requirements, including Validation Program requirements? Please explain:

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Our company values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment.


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