Process Engineer - Solution Preparation

Responsibilities

• Support the design, build, commissioning, and qualification of new equipment and systems for drug substance production.
• Participate in FATs, SATs, installation, commissioning, and qualification activities for Solution Preparation equipment in alignment with GMP requirements.
• Provide system ownership and technical support for biopharmaceutical process equipment, including single-use mixers, downflow booths, scales, and CIP skids.
• Identify and implement engineering-based improvements to equipment and unit operation reliability.
• Execute master maintenance programs to ensure spare parts availability and coordinate maintenance activities with OEMs.
• Perform technical root cause analysis and implement corrective/preventive actions to reduce production downtime.
• Assist with new product and technology introductions through facility fit assessments and equipment modifications.

Requirements

• Bachelor's degree in Engineering with 4 years of experience, or equivalent combination of education and experience.
• Experience in biopharmaceutical operations or manufacturing environments.
• Knowledge of Solution Preparation equipment (e.g., Single-use Mixers, Scales, Stainless Prep/Hold Vessels).
• Familiarity with cGMP, OSHA, and EPA regulated environments.
• Proficiency in data-driven problem solving, including Root Cause Analysis (RCA) or Statistical Process Control (SPC).
• Ability to work a flexible schedule to support 24/7 manufacturing operations, including rotational on-call support.

Preferred Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering.
• 6+ years of relevant work experience with 5+ years specifically in biopharmaceutical manufacturing.
• Direct experience with CIP/SIP skids and biologics manufacturing technologies.
• Experience managing capital projects, including procurement, construction, and validation.

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, Amgen has pioneered advancements in oncology, inflammation, general medicine, and rare diseases. Our award-winning culture is collaborative, innovative, and science-based, focusing on delivering innovative medicines that help people live longer, fuller, and happier lives.