Clean Utilities Sr Engineer

Amgen • Holly Springs, NC

6d • $115,495 - $156,257

About The Position

The Clean Utilities Sr. Engineer joins Amgen’s Facilities & Engineering group and partners with corporate engineering to design, build, commission, and qualify equipment and systems used in drug substance production. The role develops subject matter expertise to support operations after startup and provides system ownership for clean and plant utility systems and equipment at the site. It reports to the Director of the Amgen North Carolina Facilities & Engineering group.

The engineer supports new or modified systems through design, construction, startup, commissioning, and qualification; identifies and implements equipment or facility improvements; and develops business cases when needed. The role also establishes equipment maintenance programs, ensures spare-parts availability, and coordinates maintenance to keep systems operational and compliant with safety, environmental, and GMP requirements.

The position supports daily operations, maintenance, and troubleshooting; monitors system performance and reduces production downtime through root cause analysis and corrective and preventive actions. It supports product and technology introductions, investigates abnormal conditions, and advances condition-based and predictive maintenance using data analytics where applicable. Work schedule flexibility may be needed to support 24/7 operations, including occasional after-hours engineering coverage. Domestic and international travel may be required.

Requirements

• One of the following education and experience combinations: high school diploma or GED and 10 years of Engineering/Maintenance experience; associate degree and 8 years; bachelor’s degree and 4 years; master’s degree and 2 years; or doctorate degree.
• Direct knowledge of design and troubleshooting for GMP biopharmaceutical production utility equipment and systems, including pharmaceutical water, clean steam, clean air generation and distribution, and supporting plant utilities such as chillers, cooling towers, steam boilers, and air compressors.
• Experience with equipment and facility control-system operation, logic, and troubleshooting.
• Ability to analyze problems and develop engineering solutions using scientific, data-driven methods such as data analytics, root cause analysis, statistical process control, Six Sigma, or predictive maintenance.
• Experience in a regulated environment, such as cGMP, OSHA, or EPA, and familiarity with GMP quality processes including change control, non-conformances, corrective and preventive actions, and qualification or validation.
• Experience applying engineering principles to system modifications, new process introductions, and capital project execution.
• Understanding of capital project execution in a GMP biopharmaceutical production facility, including procurement, construction, startup, and validation.
• Understanding of safety requirements in a GMP biopharmaceutical production facility.
• Ability to work independently, stay organized, and multitask in project environments; communication, facilitation, and teamwork skills.
• Strong leadership, technical writing, communication, and presentation skills.
• Schedule flexibility to support 24/7 operations, including occasional after-hours engineering coverage.
• Ability to travel domestically and internationally.

Nice To Haves

• Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering.
• Four or more years of relevant work experience, including two or more years in a biopharmaceutical operations or manufacturing environment.

Responsibilities

• Own clean and plant utility systems and equipment supporting site operations.
• Provide engineering support for the design, construction, startup, commissioning, and qualification of new or modified systems.
• Identify, support, or lead engineering improvements and upgrades to equipment and facility systems, and develop business cases when required.
• Develop equipment maintenance programs, ensure spare parts are available, and coordinate maintenance execution.
• Ensure systems are safely installed and operated in compliance with applicable environmental, health, and safety practices, rules, and regulations.
• Ensure system commissioning and qualification align with GMP requirements and interact with regulatory inspectors as necessary.
• Apply engineering principles to daily operation, maintenance, and troubleshooting of plant systems.
• Monitor systems for performance risks and implement risk-reduction strategies.
• Provide troubleshooting support to reduce production downtime, including leading or supporting technical root cause analysis and corrective and preventive action implementation.
• Support new product and technology introductions through engineering assessments, equipment modifications, and engineering runs.
• Advance condition-based and predictive maintenance practices using advanced data analytics where applicable.
• Own investigations of abnormal conditions through deviation and business processes.

Benefits

• Retirement and Savings Plan with company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Time-off plans.
• Flexible work models where possible.
• Career development opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed