Engineering and Validation Expert

4 weeks ago


Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full time
Company Overview

Takeda Pharmaceutical is a forward-thinking, global healthcare company that prioritizes innovation and patient care. Our R&D organization is committed to developing novel therapies and delivering transformative treatments worldwide.

Salary and Benefits

The estimated salary for this role is $84,000 - $132,000 per year, depending on experience and qualifications. U.S.-based employees may also be eligible for short-term and long-term incentives, as well as comprehensive benefits including medical, dental, vision insurance, 401(k) plan, and more.

About the Role
  • Evaluate equipment installation, calibration, qualification, maintenance, and decommissioning in accordance with GxP regulations and internal SOPs.
  • Schedule and complete equipment preventative maintenance and calibration activities using Blue Mountain Regulatory Asset Management System.
  • Act as a liaison between cross-functional groups to ensure adherence to quality processes and compliance standards.
Required Skills and Qualifications
  • Associate degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 4+ years of relevant industry experience.
  • Bachelor's degree in chemistry, biology, pharmacy, engineering, or related pharmaceutical science with 2+ years of relevant industry experience.
  • Working knowledge of cGMP, GxP, GAMP, and 21CFR part 11 requirements.
  • Experience with validation lifecycle approach (URS, DQ, IQ, OQ, PQ, etc.).
Why Join Takeda?

We are certified as a Global Top Employer and strive to create an inclusive, collaborative workplace where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.



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