Senior Validation Engineer

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.

The Senior Validation Engineer will oversee strategies and documents related primarily to FDP (Finished Drug Product) product specific qualifications (eg., OQ, PQ, and/or PPQ) at contract manufacturing organizations (CMOs) located primarily in the JAPAC region, but occasionally in EU or North America. Direct experience with qualification/validation of primary and secondary packaging processes, including device / combination products is required. The candidate should have some experience and understanding of implementing statistical methods for determining appropriate sampling plans and acceptance criteria, based on level of risk. Experience with validation of synthetic API manufacturing processes is also highly desired. Prior experience with, or willingness to learn, other modalities, including biologic drug substance and aseptic drug product is also desired. The candidate should be able to travel within the JAPAC region, specifically Japan.