Sr Engineer I - Downstream

Responsibilities

• Provide system ownership for biopharmaceutical process equipment, including design, construction, and validation.
• Lead implementation of engineering-based improvements and upgrades to facility systems.
• Collaborate with Manufacturing, Quality, and Process Development teams to ensure reliable plant operations.
• Develop equipment maintenance programs and ensure the availability of critical spare parts.
• Ensure commissioning and qualification of systems align with GMP requirements and regulatory standards.
• Perform technical root cause analysis to reduce production downtime and implement corrective actions.
• Support new product and technology introductions through engineering assessments and equipment modifications.
• Provide rotational on-call support to ensure 24/7 reliability of Upstream and Downstream systems.

Requirements

• Bachelor's degree and 4 years of Engineering experience, OR Master's degree and 2 years of experience, OR Doctorate degree.
• Ability to work the 2nd shift (3pm to 11pm, Monday through Friday).
• Experience in a regulated environment (e.g., cGMP, OSHA, EPA).
• Strong problem-solving skills using data-driven techniques such as Root Cause Analysis (RCA) or Six Sigma.
• Ability to travel domestically or internationally approximately 10%.

Preferred Qualifications

• Bachelor's degree in Chemical or Mechanical Engineering.
• 6+ years of relevant work experience, with 5+ years specifically in Biopharmaceutical downstream operations.
• Direct knowledge of chromatography, centrifugation, and tangential flow filtration.
• Familiarity with equipment such as cell culture reactors, autoclaves, CIP systems, and water for injection.
• Experience with capital projects, including procurement, construction, and startup in a GMP facility.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement and Savings Plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans.

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, leveraging biologics manufacturing expertise to improve health outcomes worldwide.