Upstream Process Engineer

Role Summary

Upstream Process Engineer position at Amgen. Support upstream manufacturing processes in Rhode Island clinical/commercial manufacturing plants, providing operational support, troubleshooting, and optimization for assigned equipment and assisting with design and implementation of new equipment.

Responsibilities

• Support system reliability and operational optimization efforts; identify risks and implement risk reduction strategies; lead or support improvement efforts for cycle time, efficiency, and yield.
• Lead or support technical root cause analysis, incident investigations, and solving equipment problems (mechanical, electrical, instrumentation, and control systems).
• Analyze problems and develop engineering solutions using data techniques (e.g., SPC, Six Sigma, predictive maintenance).
• Support new product or technology introductions through engineering assessments, equipment modifications, and engineering runs.
• Apply process engineering principles in design, construction, startup, and validation of process equipment and systems for capital projects; experience with project engineering from concept to operations turnover.
• Translate design requirements into process equipment/system solutions; perform engineering studies for process equipment systems, clean utilities, and facility improvements.
• Demonstrate ability to translate production processes into detailed designs; apply standard engineering principles; employ basic techniques within engineering scope.
• Support a safe working environment by following environmental health and safety practices and regulations.

Qualifications

• Required: High school diploma/GED with 8 years of engineering experience, or Associate‚Äôs degree with 6 years, or Bachelor‚Äôs degree with 2 years, or Master‚Äôs degree.
• Preferred: Bachelor‚Äôs degree in Chemical, Mechanical, or Bioengineering; 3+ years of relevant experience with 1+ year in operations/manufacturing; direct experience in regulated environments (FDA, cGMP, OSHA, EPA); hands-on experience with manufacturing process equipment and troubleshooting; experience with fermenters, bioreactors, centrifuges, chromatography, ultrafiltration/defiltration; strong knowledge of cGMP and validation practices; experience with bulk biopharmaceutical production facilities; ability to work independently and in teams; strong communication and leadership skills; flexibility to support 24/7 operations including after-hours and on-call.

Skills

• Strong problem-solving and analytical skills (data analysis, SPC, Six Sigma).
• Engineering design and project execution capabilities for process equipment and systems.
• Effective communication, technical writing, and collaboration.
• Ability to translate production needs into concrete design and process improvements.

Education

• As listed in Qualifications above (degree requirements per level).

Additional Requirements

• Ability to work flexible schedule to support 24/7 operations; occasional after-hours coverage and on-call support.