Senior Biopharma Process Engineer

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybride; USD 120 000 - 170 000; Plein temps

Résumé du poste

Amgen is seeking a Senior Engineer to provide engineering support for Drug Substance facilities. You will lead improvements, coordinate maintenance, and ensure systems meet safety and regulatory standards during commissioning and validation.

Ideal candidates will bring advanced engineering degrees and extensive GMP biopharma experience, with leadership, data-driven problem-solving, and strong communication skills to drive continuous improvement and support 24/7 operations.

Qualifications

• Doctorate in engineering or related field required.
• Advanced degree with 2+ years engineering experience or equivalent.
• Bachelor’s with 4+ years engineering experience or higher.
• Extensive exposure to GMP biopharma environments preferred.

Responsabilités

• Implement engineering improvements and equipment upgrades with business-case development.
• Coordinate maintenance to ensure systems are in good order.
• Ensure commissioning/qualification and regulatory interface as needed.
• Develop metrics to measure maintenance effectiveness and performance.
• Troubleshoot to reduce downtime and lead root-cause analyses.
• Support new product introductions and capital projects.

Connaissances

Leadership

Technical writing

Communication

Multi-tasking

Formation

Doctorate degree

Master’s degree + 2 yrs experience

Bachelor’s degree + 4 yrs experience

Associate’s degree + 8 yrs experience

High school diploma / GED + 10 yrs experience

Outils

GMP equipment

Autoclaves

CIP systems

Clean steam

Description du poste

Amgen is seeking a Senior Engineer to provide engineering support for Drug Substance facilities. You will lead improvements, coordinate maintenance, and ensure systems meet safety and regulatory standards during commissioning and validation.

Ideal candidates will bring advanced engineering degrees and extensive GMP biopharma experience, with leadership, data-driven problem-solving, and strong communication skills to drive continuous improvement and support 24/7 operations.