Process Engineer - Solution Prep, Upstream, and Downstream

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

About the Role Join Amgen’s Facilities & Engineering (F&E) group to design, build, commission, and qualify equipment and systems for drug substance production, and to develop domain expertise to support operations at startup. You’ll collaborate with the corporate engineering team to ensure GMP-compliant, safe, and regulatory-ready systems across design, construction, commissioning, qualification, and ongoing operations.

What You'll Do

• Provide site design, construction, start-up, and operational readiness; support commissioning and qualification of manufacturing systems in alignment with GMP requirements; interact with regulatory inspectors.
• Ensure systems are installed, operate safely, and comply with environmental health/safety practice, rules and regulations; support qualification activities and communicate regulatory compliance as a manufacturing systems owner.
• Assist with new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Site Operations: provide system support for biopharmaceutical process equipment; identify and implement engineering-based improvements or upgrades; translate design requirements into equipment specifications and support construction, startup, and validation of improvements.
• Develop equipment maintenance programs; ensure the availability of spare parts; coordinate maintenance activities to keep systems in proper working order; provide system guidance to identify performance risks and implement risk-reduction strategies.
• Provide problem-solving support to reduce production downtime, including technical root cause analysis and implementation of corrective/preventive actions.
• Provide rotational on-call and/or shift support to ensure 24x7 day-to-day reliability of Solution Prep, Upstream and Downstream systems; travel onsite and up to 10% domestic/international as needed.

What We're Looking For

• Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of Engineering experience OR Associate’s degree and 6 years of Engineering experience OR High school diploma / GED and 8 years of Engineering experience.
• Preferred Qualifications: Bachelor’s degree in Chemical or Mechanical Engineering or similar; 3+ years relevant experience with 2+ years in Biopharmaceutical operations/manufacturing environment.
• Direct knowledge of GMP Biopharmaceutical Production facility equipment/systems with experience in Solution Prep, Upstream, and Downstream purification equipment and other support equipment.
• Ability to analyze problems and propose engineering solutions using data-driven techniques.
• Experience in regulated environments and familiarity with GMP quality systems/processes.
• Experience applying engineering principles to design and implementation of system modifications and introduction of new processes.

Nice to Have

• Bachelor’s degree in Chemical or Mechanical Engineering or similar.
• 3+ years of relevant work experience with 2+ years in Biopharmaceutical operations/manufacturing environment.
• Direct knowledge of GMP Biopharmaceutical Production facility equipment/systems with hands-on experience with Solution Prep, Upstream, and Downstream purification equipment and related support systems.
• Experience with data-driven problem solving and process improvement methodologies.

Compensation & Benefits Salary information not disclosed in the posting. Benefits details are not provided in the available text.