Senior Process Engineer

Senior Process Engineer

How might you defy imagination? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest disposable technologies with traditional stainless‑steel equipment to allow for maximum flexibility in operations. The facility features best‑in‑class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and sustainability innovations to reduce carbon and waste as part of Amgen's plan to be a carbon‑neutral company.

Let’s do this. Let’s change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise and system ownership to support process operations, focusing on Downstream Process engineering.

• Provide system ownership for biopharmaceutical process equipment and identify, support, or lead engineering‑based improvements or upgrades to equipment or facility systems, including development of business cases, design requirements, and translation of requirements into process equipment/system design, specifications, and support for construction, startup, and validation.
• Effectively collaborate with key customers and support groups (e.g., Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to keep systems in proper working order.
• Ensure systems are installed and operate safely and remain in sync with environmental health and safety practices, rules, and regulations.
• Ensure commissioning and qualification of systems are completed in alignment with GMP requirements and interact with regulatory inspectors.
• Provide guidance to identify performance risks and implement risk‑reduction strategies.
• Provide problem‑solving support to reduce production downtime, including leading technical root‑cause analysis and implementing corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Provide rotational on‑call support and ensure 24/7 day‑to‑day reliability of upstream and downstream systems for plant operations.
• Provide technical mastery and problem‑solving leadership to proactively reduce production downtime, leading technical root‑cause analysis and implementation of corrective/preventive actions for families of systems.
• Ensure plant readiness and compliance for internal audits, external agency audits, and partner audits for the process equipment.
• Lead new product/technology introductions through engineering assessments, performance risk assessments, gap identification, remediation ownership, equipment modifications, and engineering runs.

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

• Doctorate degree
• Master’s degree and 2 years of engineering experience
• Bachelor’s degree and 4 years of engineering experience
• Associate’s degree and 8 years of engineering experience
• High school diploma / GED and 10 years of engineering experience

• Bachelor’s degree in Chemical or Mechanical Engineering
• 6+ years of relevant work experience, including 5+ years in a biopharmaceutical operations/manufacturing environment with a focus…