Senior ManagerProcessEngineering - Bulk Drug Substance - Downstream

Senior Manager – Process Engineering (Downstream)

Responsible for overseeing an engineering team that designs, develops, and maintains process equipment and systems for downstream purification and clean‑in‑place (CIP/SIP) operations at Amgen's new FleX batch facility.

• Site design, construction, start‑up, and operational readiness.
• Commissioning and qualification of process equipment in compliance with GMP requirements.
• Ensure operational safety and environmental compliance.
• Perform engineering assessments and implement equipment modifications for new product introductions.
• Provide system ownership for downstream purification equipment (chromatography, viral filtration, UF/DF, CIP/SIP skids).
• Lead, manage, and develop a team of process engineers, serving as the main point of contact for process and equipment engineering functions.
• Set clear expectations, develop staff, and foster continuous improvement and knowledge sharing.
• Collaborate with key stakeholders—manufacturing, quality, process development, maintenance, and network partners—to support plant operations.
• Coordinate maintenance, both breakdown and planned, with OEMs and service providers.
• Identify and implement engineering‑based improvements, develop business cases, and support construction, start‑up, and validation activities.
• Maintain equipment maintenance programs and spare part availability.
• Ensure plant readiness and compliance for internal and external audits.
• Provide technical troubleshooting support and risk mitigation guidance.
• Deliver strategic, tactical management and leadership to ensure 24/7 reliability of plant operations.
• Participate in budgeting—forecast costs, manage expenditures, and allocate resources efficiently.
• Support 10% domestic and international travel.

• High School diploma/GED and at least 12 years of engineering experience; or
• Associate's degree and 10 years of engineering experience; or
• Bachelor's degree and 8 years of engineering experience; or
• Master's degree and 6 years of engineering experience; or
• Doctorate and 2 years of engineering experience.
• Minimum 2 years of direct people management or leadership experience.

• Bachelor's degree in Chemical, Mechanical, or related engineering field.
• 8+ years of relevant experience with 5+ years in biopharmaceutical manufacturing, focused on process and plant engineering.
• Demonstrated people‑management/leadership experience.
• Direct experience with downstream purification and CIP/SIP skids.
• Experience in tech transfer, process design, commissioning & qualification.
• Experience in regulated environments (cGMP, OSHA, EPA) and familiarity with GMP systems such as change control and validation.
• Knowledge of equipment design and operation in biopharmaceutical production.
• Strong communication, facilitation and teamwork skills.
• Ability to apply analytical skills to complex problems.
• Flexibility for after‑hours coverage to support 24/7 operations.

Competitive base salary and comprehensive total rewards package aligned with local industry standards, supporting professional and personal growth in a collaborative science‑based culture.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. Amgen will provide reasonable accommodation to individuals with disabilities.