Senior Engineer - Drug Substance Facilities

About the role

Amgen is hiring a Senior Engineer to support its Drug Substance facilities. Working with the Sr. Engineering Manager, the engineer provides engineering support, leads equipment and facility improvements, coordinates maintenance and helps ensure systems meet quality and safety standards. Up to 10% domestic travel is required.

Key responsibilities

• Identify, support and lead engineering improvements or upgrades to equipment and facility systems, including business cases, design requirements and specifications, and supporting construction, startup and validation.
• Coordinate equipment maintenance so systems stay in proper working order, and ensure commissioning and qualification of systems are completed.
• Interact with inspectors and develop metrics-based performance measures for maintenance systems and operating levels.
• Provide troubleshooting support, including leading or supporting root cause analysis and corrective and preventive actions, and second-tier troubleshooting for operations and maintenance.
• Support new products and technologies through engineering assessments, equipment modifications, spare parts identification, job plans and engineering runs.
• Ensure installations meet safety requirements and environmental health and safety regulations.
• Determine CAPAs, own the record, initiate child CAPAs and CAPA EVs, close them timely, and provide technical data and reports.
• Establish equipment monitoring parameters and control limits, run change-over reduction and failure trending projects, and give regular metric updates.

Required profile

• Basic: doctorate, or master's degree with 2 years of engineering experience, or bachelor's degree with 4 years, or associate's degree with 8 years, or high school diploma with 10 years of engineering experience.
• Preferred: bachelor's degree in Biotechnology, Industrial, Chemical or Mechanical Engineering; 6+ years of relevant experience, including 5+ in biopharmaceutical manufacturing; experience in a regulated environment (cGMP, OSHA, EPA) and familiarity with GMP quality systems such as change control, non-conformances and CAPAs.
• Preferred: direct knowledge of GMP biopharmaceutical equipment such as cell culture reactors, chromatography, filtration, filling, lyophilization, CIP systems and water for injection.
• Preferred: ability to use RCA, SPC, Six Sigma and predictive maintenance, and understanding of capital project execution in GMP facilities.
• Preferred: flexibility for 24/7 operations, with occasional after-hours coverage.

What we offer

• Annual salary range posted for the U.S. (excluding Puerto Rico), varying with skills, experience and qualifications.
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and flexible work models where possible.