Senior Process Engineer

Overview

Senior Process Engineer – Downstream Process Engineering.

The role supports the Facilities & Engineering team at Amgen’s new FleX Batch drug substance manufacturing plant, partnering with corporate engineering to design, build, commission, and qualify equipment and systems for drug substance production.

• Own and maintain biopharmaceutical process equipment, ensuring reliability and compliance.
• Identify, design, and implement engineering improvements or upgrades to equipment and facility systems, including developing business cases and translating requirements into specifications.
• Support construction, startup, and validation of process equipment and systems.
• Collaborate with key customers and support groups (Manufacturing, Quality, Process Development, Maintenance, Network Partners) to meet operational and regulatory goals.
• Develop maintenance programs, manage spare parts, and coordinate maintenance activities to keep systems in working order.
• Ensure system safety, environmental health and safety compliance, and alignment with GMP requirements during commissioning, qualification, and audits.
• Conduct root cause analysis and implement corrective/preventive actions to reduce production downtime.
• Lead engineering assessments for new product/technology introductions and support engineering runs.
• Provide rotational on‑call support, guaranteeing 24/7 reliability of upstream and downstream systems.

• Doctorate, Master’s degree with 2+ years engineering experience, Bachelor’s degree with 4+ years engineering experience, or Associate’s degree with 8+ years engineering experience.
• High school diploma / GED with 10+ years engineering experience.

• Bachelor’s degree in Chemical or Mechanical Engineering.
• 6+ years of relevant work experience, including 5+ years in biopharmaceutical manufacturing focusing on downstream unit operations.
• Direct knowledge of GMP biopharmaceutical equipment and systems (cell culture reactors, centrifugation, chromatography, tangential flow filtration, CIP systems, etc.).
• Proficiency in data‑driven problem analysis (Data Analytics, Root Cause Analysis, SPC, Six Sigma, Predictive Maintenance).
• Experience in a regulated environment (cGMP, OSHA, EPA) and familiarity with GMP quality systems (change control, non‑conformances, corrective/preventive actions, validation).
• Experience in capital project oversight, including procurement, construction, startup, and validation of GMP biopharmaceutical facilities.
• Strong understanding of safety requirements in a GMP environment.
• Independent, organized, multi‑tasking, and able to work in project‑based, team‑oriented settings.
• Excellent leadership, technical writing, and communication/presentation skills.
• Flexibility for 24/7 operations, including occasional after‑hours coverage.
• Domestic/international travel (~10%).

• Comprehensive employee benefits package: retirement and savings plan with company contributions, group medical, dental, vision, life and disability insurance, flexible spending accounts.
• Discretionary annual bonus program.
• Stock‑based long‑term incentives.
• Generous time‑off plans and bi‑annual company shutdowns.
• Flexible work models, including remote work where possible.
• Career development opportunities.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Amgen will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

Salary Range:  USD –  USD