Senior Biopharma Downstream Process Engineer

Amgen Inc. (IR)

Holly Springs, Northern (NC, KY)

Hybrid

USD 115,000 - 156,000

Full time

3 days ago

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Benefits offered by this job

Total rewards package

Flexible work arrangements

Job summary

Amgen Inc. in North Carolina is seeking a Senior Process Engineer to join the Facilities & Engineering group at the FleX Batch site. You will own downstream biopharmaceutical equipment, design and validate new systems, and partner with manufacturing, QA, and maintenance to ensure continuous, compliant production.

The role emphasizes equipment qualification, risk reduction, and support for 24/7 operations with a focus on process efficiency and regulatory readiness.

Qualifications

Advanced degree with engineering experience in biopharma operations.
Experience with GMP biopharma production facilities and equipment.
Strong problem-solving using data-driven methods.

Responsibilities

Provide system ownership for Biopharmaceutical process equipment.
Design, build, commission, and qualify new equipment and systems.
Lead/evaluate reliability improvements and risk-reduction actions.
Support 24/7 operations and on-call technical coverage.
Ensure regulatory readiness and participate in audits.

Skills

Biopharma ops

Downstream ops

GMP knowledge

Root cause analysis

Data analytics

Six Sigma

Education

PhD in Engineering

MS in Engineering

BS in Chemical or Mechanical Eng

AS or related 8+ years exp

Tools

Chromatography

TFF (Tangential Flow Filtration)

Autoclaves

CIP systems

Clean steam

WFI systems

Job description

The role emphasizes equipment qualification, risk reduction, and support for 24/7 operations with a focus on process efficiency and regulatory readiness.

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