Senior Process Engineer - Solution Prep, Upstream, and Downstream

Job title: Senior Process Engineer - Solution Prep, Upstream, and Downstream

About the Role Senior Process Engineer in Amgen's Facilities & Engineering group will partner with the corporate engineering team to design, build, commission, and qualify new equipment and systems for drug substance production, with a focus on Solution Prep, Upstream, and Downstream operations.

What You'll Do

• Design, build, commission, and qualify manufacturing equipment and systems, aligning design reviews with site requirements (equipment design and sizing, architecture and electrical distribution, and P&ID development).
• Support factory acceptance testing with global engineering; review protocols and resolve punch list items.
• Work with the capital project team to ensure systems are installed and operate safely, complying with EH&S, regulations, and Amgen engineering standards; ensure installations meet design requirements.
• Execute and guide commissioning and validation to ensure operational capability aligns with manufacturing needs and GMP; ensure on-time project delivery.
• Support engineering and performance qualification runs; provide hypercare support as needed.
• Perform engineering assessments for plant equipment operations; implement modifications and support engineering runs for new product/technology introductions.
• Site Operations: be the system owner for Solution Prep, Upstream, and Downstream drug substance equipment; collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners to ensure reliable operations.
• Manage maintenance with OEMs for breakdowns and planned maintenance; identify and implement engineering improvements; develop and translate requirements into designs, specs, and construction activities.
• Develop master maintenance programs, ensure spare parts availability, and coordinate maintenance activities.
• Ensure plant readiness and regulatory compliance for internal and external audits.
• Provide technical leadership to reduce downtime; lead root cause analysis and corrective/preventive actions.
• Lead new product/technology introductions with assessments and remediation planning; support engineering runs.
• Provide rotational on-call and/or shift support to ensure 24x7 reliability; travel up to 10% domestically/internationally.

What We're Looking For

• Basic Qualifications: Doctorate; OR Master's degree with 2+ years of engineering experience; OR Bachelor's degree with 4+ years of engineering experience; OR Associate's degree with 8+ years of engineering experience; OR High school diploma/GED with 10+ years of engineering experience.
• Experience in process engineering related to drug substance production; ability to design, commission, validate, and qualify equipment; familiarity with GMP and regulatory requirements.
• Strong collaboration and communication skills; ability to work cross-functionally with Manufacturing, Quality, Process Development, and Maintenance teams.
• Willingness and ability to travel up to 10% (domestic/international).

Compensation & Benefits

• Not disclosed in the posting.

About Amgen Amgen is dedicated to serving patients with serious illnesses through biotechnology innovations and a focus on Oncology, Inflammation, General Medicine, and Rare Disease. The FleX Batch facility aims to combine disposable technologies with stainless steel equipment to enable flexible drug substance manufacturing, embedding Industry 4.0 capabilities and sustainability initiatives.