Role Description:

In this role you will be serving patients through internal collaboration with Amgens global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgens 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.

Roles & Responsibilities:
- Be an integral quality member of Amgen cross-functional contract manufacturing teams that includes but is not limited to operations, analytical science, process development, supply chain, etc. Project teams will include: tech transfers, recent product introductions, and ongoing validation maintenance activities.
- Translate Amgen requirements into the language of the CMO
- Identify and assess validation/quality risks to enable risk-based decisions
- Validation document author/approver
- Oversight of packaging process qualification, device and combination product qualifications.
- Determine appropriate sample plans and acceptan

📌 Senior Validation Engineer (Hyderabad)
🏢 Amgen
📍 Hyderabad