Senior Process Engineer - Clean Utilities

Amgen - Holly Springs, NC

Full-time - Mid Level

Hybrid - Holly Springs, NC

Chemical Manufacturing

About the position

As a Senior Process Engineer in Clean Utilities at Amgen, you will play a crucial role in the Facilities & Engineering group, collaborating with the corporate engineering team to design, build, commission, and qualify new equipment and systems for drug substance production. This position involves system ownership for biopharmaceutical process equipment, leading engineering improvements, and ensuring compliance with GMP requirements. You will also develop maintenance programs, support new product introductions, and provide problem-solving support to minimize production downtime, all while contributing to Amgen's mission of serving patients with serious illnesses.

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Provide system ownership for biopharmaceutical process equipment.
• Identify and implement engineering-based improvements or upgrades to equipment or facility systems.
• Develop business cases for improvements and translate requirements into process equipment/system design.
• Support construction, startup, and validation of equipment.
• Develop equipment maintenance programs and ensure availability of spare parts.
• Coordinate maintenance activities to ensure systems are operational and compliant with safety regulations.
• Ensure commissioning and qualification of systems align with GMP requirements and interact with regulatory inspectors.
• Identify performance risks and implement risk reduction strategies.
• Lead and support technical root cause analysis and corrective/preventive actions to reduce production downtime.
• Support new product/technology introductions by performing engineering assessments and implementing equipment modifications.

Requirements

• Doctorate degree OR Master's degree and 3 years of Engineering experience OR Bachelor's degree and 5 years of Engineering experience OR Associate's degree and 10 years of Engineering experience OR High school diploma / GED and 12 years of Engineering experience.
• Bachelor's degree in Chemical or Mechanical Engineering preferred.
• 6+ years of relevant work experience with 5+ years in Biopharmaceutical operations/manufacturing environment.
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems.
• Ability to analyze problems and develop engineering solutions using data-driven techniques.
• Experience working in a regulated environment (e.g., cGMP, OSHA, EPA).
• Familiarity with GMP quality systems/processes such as change control and qualifications/validation.
• Understanding of capital projects in a GMP Biopharmaceutical Production facility.

Nice-to-haves

• Experience applying engineering principles to the design and implementation of system modifications.
• Understanding of safety requirements in a GMP Biopharmaceutical Production facility.
• Strong leadership, technical writing, and communication/presentation skills.

Benefits

• Comprehensive employee benefits package including health and welfare plans.
• Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.