Lead Biopharma Process Engineer, Upstream/Downstream

Amgen SA; Holly Springs, Northern (NC, KY); Hybrid; USD 140,000 - 190,000; Full time

Job summary

Amgen is seeking a Principal Process Engineer - Upstream/Downstream to join the Facilities & Engineering group. You will lead design, construction, start-up and qualification of systems for drug substance production, partnering with corporate engineering to ensure compliance with GMP regulations and project timelines.

You will supervise and mentor engineering staff, oversee commissioning, qualification runs, and 24/7 operations readiness while collaborating with Manufacturing, Quality,

Qualifications

• Doctorate degree and 2 years of engineering experience required.
• Master’s degree and 4 years of engineering experience required.
• Bachelor’s degree and 6 years of engineering experience required.
• Associate’s degree and 10 years of engineering experience required.
• High school diploma / GED and 12 years of engineering experience required.

Responsibilities

• Design, build, and qualify new equipment and systems for drug substance production.
• Lead technical projects and drive innovation in product design and manufacturing processes.
• Provide leadership and guidance to the engineering team for 24/7 manufacturing operations.
• Coordinate with Manufacturing, Quality, Process Development and Maintenance groups.
• Manage design reviews, FAT, and site installation activities with global engineering partners.
• Mentor junior engineers and communicate automation and control needs to stakeholders.

Skills

Leadership

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen is seeking a Principal Process Engineer - Upstream/Downstream to join the Facilities & Engineering group. You will lead design, construction, start-up and qualification of systems for drug substance production, partnering with corporate engineering to ensure compliance with GMP regulations and project timelines.

You will supervise and mentor engineering staff, oversee commissioning, qualification runs, and 24/7 operations readiness while collaborating with Manufacturing, Quality,