Process Engineer - Solution Prep, Upstream and Downstream

About the role

Amgen is hiring a Process Engineer for its new FleX batch facility, which combines disposable technologies with traditional stainless steel equipment and integrates Industry 4.0 and sustainability features. You will join the Facilities & Engineering group and partner with the corporate engineering team to design, build, commission and qualify new equipment and systems for drug substance production, then support operations after start-up.

Key responsibilities

• Commission and qualify manufacturing systems in line with GMP requirements and interact with regulatory inspectors as a manufacturing systems owner
• Ensure systems operate safely and comply with environmental, health and safety rules
• Support new product and technology introductions through engineering assessments, equipment modifications and engineering runs
• Provide system support for biopharmaceutical process equipment and identify engineering-based improvements, including business cases, design requirements and validation
• Develop equipment maintenance programs, manage spare parts and coordinate maintenance
• Support root cause analysis, corrective and preventive actions and provide rotational on-call or shift support for 24/7 reliability of Solution Prep, Upstream and Downstream systems
• Travel domestically and internationally up to 10%

Required profile

• Master's degree, or Bachelor's degree with 2 years of engineering experience, or Associate's degree with 6 years, or high school diploma with 8 years of engineering experience
• Preferred: Bachelor's degree in Chemical or Mechanical Engineering or similar, and 3+ years of experience including 2+ in biopharmaceutical operations
• Ability to travel domestically and internationally
• Flexibility for occasional after-hours coverage to support 24/7 operations

Required skills

• Knowledge of GMP biopharmaceutical equipment such as weigh and dispense, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, UFDF skids, autoclaves, CIP systems and water for injection
• Problem-solving using data analytics, root cause analysis, statistical process control, Six Sigma and predictive maintenance
• Experience in regulated environments (cGMP, OSHA, EPA) and familiarity with change control, non-conformances and validation
• Technical writing, communication and presentation skills