Senior Quality Engineer – Amgen

Looking for a Senior Quality Engineer Job in Hyderabad? BiotechReality JobFinder is excited to share a brand-new opening at Amgen, one of the world’s premier biotechnology organizations. Amgen is rapidly expanding its technical presence in India and is seeking a highly skilled individual to fill the role of Senior Quality Engineer (Job ID: R-216598) at its high-tech capability center in Hyderabad.

Role Overview

Amgen is globally recognized for its inclusive culture, cutting-edge therapeutic discoveries, and deep commitment to employee career acceleration. Securing this Senior Quality Engineer Job in Hyderabad means you will act as a pivotal Quality Engineering representative on multi-functional teams. You will take ownership of quality processes across various stages of product development and commercialization, maximizing both patient safety and operational excellence.

Responsibilities

In this vital role, the successful candidate will provide quality technical expertise and oversight for combination and non-combination medical products. The scope spans a diverse product portfolio, including vials, prefilled syringes, fluid transfer devices, and electromechanical on-body injector systems.

1. Quality Oversight: Reviewing and managing core design controls, Change Control protocols, and NC/CAPA (Non-Conformance and Corrective and Preventive Action) procedures.

2. Testing Methods: Providing oversight on the qualification, validation, and maintenance of physical test methods, including precise sample selection.

3. Human Factors Engineering: Contributing to the review of Human Factors Engineering (HFE) Protocols, alongside onboarding and auditing HFE suppliers.

4. Inspection Readiness: Assisting with content generation for regulatory submissions, responding to RTQs (Requests to Questions), and supporting active site audits.

Requirements and Qualifications

1. Doctorate Degree, OR

2. Master’s Degree with 4 to 6 years of direct Quality experience, OR

3. Bachelor’s Degree with 6 to 8 years of direct Quality experience, OR

4. Technical Diploma with 10 to 12 years of direct Quality experience.

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Preferred Skills

1. 5+ years of quality and manufacturing experience strictly within the biotechnology or pharmaceutical industry.

2. Deep working knowledge of international standards, including ISO 14971, ICH Q9, ICH Q10, and ISO 13485 Medical Devices Standard.

3. Prior experience executing standard regulations such as 21 CFR parts 4, 210, 211, and 820.

4. Willingness to travel approximately 15-20% of the time to domestic and international Amgen sites.