Engineering and Quality Assurance Specialist

3 weeks ago


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

At Takeda Pharmaceutical, we are dedicated to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to protected characteristics. As an Engineering and Quality Assurance Specialist, you will play a vital role in ensuring compliance with regulatory requirements and quality standards.

About the Role

You will be responsible for installing, calibrating, qualifying, maintaining, and decommissioning equipment according to GxP regulations and internal SOPs. Additionally, you will schedule and complete preventative maintenance and calibration activities in Blue Mountain Regulatory Asset Management System, act as a liaison between cross-functional groups, and develop documentation associated with assigned CQV discipline(s).

This role requires strong technical expertise, excellent communication skills, and a working understanding of cGMP, GxP, GAMP, and 21CFR part 11 requirements. Experience with validation lifecycle approaches, investigations, and deviations in a pharmaceutical manufacturing environment is also essential.

About Us

Takeda is a patient-focused company that inspires and empowers its employees to grow through life-changing work. We are certified as a Global Top Employer and offer a stimulating career path, encouraging innovation, and striving for excellence in everything we do.

We believe in fostering an inclusive, collaborative workplace, where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people worldwide.

Some of the benefits of joining Takeda include:

  • U.S. Base Salary Range: $84,000 - $132,000 per year
  • A comprehensive benefits package, including medical, dental, vision insurance, 401(k) plan, and company match
  • Short-term and long-term incentives
  • Up to 80 hours of sick time and up to 120 hours of paid vacation

Please note that this estimate is based on the location and level of experience required for this position.



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