Engineering and Validation Expert
4 weeks ago
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 BenefitsThe 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.
- 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.).
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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