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Sr Engineer

Job in Holly Springs, Wake County, North Carolina, 27540, USA
Listing for: Amgen
Full Time position
Listed on 2026-06-26
Job specializations:
  • Engineering
    Validation Engineer, Quality Engineering, Process Engineer, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 80000 - 110000 USD Yearly USD 80000.00 110000.00 YEAR
Job Description & How to Apply Below
Position: Sr Engineer I

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas – Oncology, Inflammation, General Medicine, and Rare Disease – we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions.

As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science‑based. If you have a passion for challenges and the opportunities that lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

S.R. Engineer I, Process Development (Downstream) What You Will Do

Let’s do this. Let’s change the world. In this vital role you will advance Amgen’s latest bioprocessing platform and technology, delivering high‑quality medicine to patients around the world.

The Sr. Engineer will be part of the Process Development–Drug Substance Technology at Amgen’s FleX Batch facility, focusing on technology transfer, process support, and optimization. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

  • Support technology transfer, process validation, and plant start‑up
  • Provide technical leadership in downstream (purification) bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life‑cycle management
  • Partner with cross‑functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
  • Provide on‑the‑floor process support as required
  • Ensure safety and compliance of process development activities
  • Collaborate with other site functions and network drug substance teams in delivering plant goals
  • Support regulatory filing, inspection, and other CMC activities
What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team‑player with these qualifications.

Basic Qualifications
  • High school diploma / GED and 10 years of biologics process development or commercial‑scale technical support experience
  • Associate’s degree and 8 years of biologics process development or commercial‑scale technical support experience
  • Bachelor’s degree and 4 years of biologics process development or commercial‑scale technical support experience
  • Master’s degree and 2 years of biologics process development or commercial‑scale technical support experience
  • Doctorate degree
Preferred Qualifications
  • Master’s degree in Engineering or Science discipline
  • 5+ years of experience in a technical role supporting biotechnology processes within regulated environments (cGMP)
  • In‑depth expertise in biologics process purification processes
  • Experience in process scale‑up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
  • Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
  • Able to apply engineering principles and statistical analysis in resolving complex issues
  • Knowledge in regulatory filings and inspections
  • Knowledge in broad aspects of biologics processing, for example cell culture, analytical methods, or product quality attributes
  • Familiarity with operational aspects of commercial biopharma manufacturing (e.g., process automation, equipment, single‑use)
What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll…

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