Clean Utilities Sr Engineer

What you will do

In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production as well as developing subject matter expertise to support operations upon start up. The Utilities System Owner reports to the Director of the Amgen North Carolina Facilities & Engineering group.

• Provide system ownership for Clean and Plant Utility systems and equipment supporting operations at the site.
• Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
• Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the equipment or facility systems.
• Lead the development of a business case if required to support the completion of the project.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
• Ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations.
• Ensure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.
• Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant systems.
• Monitor systems to identify performance risks and implement risk reduction strategies.
• Provide troubleshooting support to reduce production downtime, including leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
• Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
• Advance the use of condition based and predictive maintenance practices by incorporating advanced data analytics where applicable.
• Own investigations of abnormal conditions through Deviation and business processes.

Basic Qualifications

• High school diploma / GED and 10 years of Engineering/Maintenance experience
• Associate's degree and 8 years of Engineering/Maintenance experience
• Bachelor's degree and 4 years of Engineering/Maintenance experience
• Master's degree and 2 years of Engineering/Maintenance experience
• Doctorate degree

Preferred Qualifications

• Bachelor's degree in Chemical, Mechanical, or Electrical Engineering
• 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility utility equipment/systems such as Pharmaceutical Water, Clean Steam, and Clean Air generation and distribution; and other Plant Utility equipment such as Chilled Water chillers, cooling towers, steam boilers, air compressors, etc.
• Experience with equipment and facility control systems operation, logic, and troubleshooting
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
• Understanding of safety requirements working in a GMP Biopharmaceutical Production facility
• Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
• Great teammate prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
• Ability for domestic/international travel