Senior Engineer (Site Mechanical) - Holly Springs, NC

Senior Engineer (Site Mechanical) - Holly Springs, NC

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Engineer (Site Mechanical)

What You Will Do

Let's do this. Let's change the world. In this vital role you will:

• The Senior Engineer (Site Mechanical) will join the Facilities & Engineering (F&E) group as a lead technical system owner for building mechanical systems supporting a large bio-pharmaceutical manufacturing site.
• Your responsibility includes HVAC and Refrigeration (HVAC/R), controlled temperature storage facilities, Life Safety Gas Detection systems, HEPA filter certification program, and the supporting mechanical utility systems.
• You will provide engineering ownership and oversight for safe and reliable daily operation of systems in accordance with established guidelines and operating procedures.
• Site design, construction, start-up, and operational readiness: Provide system ownership during capital project execution phases, focusing on building mechanical, HVAC/R systems, Life Safe Gas Detection systems, and subsystems.
• Collaborate with capital project team to ensure systems are designed, installed and operated safely, in compliance with pertinent environmental health/safety practices, regulations, as well as Amgen procedures and standards.
• Support equipment factory test and site acceptance test (FAT/SAT) activities.
• Support installation, commissioning, and qualification of Mechanical and HVAC systems and work with Qualified Building Automation System (QBAS) system provider (OEM), Amgen Engineering Technical Authority (ETA), Amgen site engineers, and other third parties to ensure Amgen user requirements are met.
• Work with and lead third-party contractors to support startup, installation check-out, and air system balancing.
• Support construction related activities, such as field verification of equipment layout, maintenance access, accurate use of materials and components (e.g. Fire Protection system), ensuring system interlocking and sequence of operations are engineered and configured accurately within the QBAS.
• Help develops standard operating procedures and maintenance practices for mechanical and HVAC systems.
• Implement master maintenance plans (MMP) and spare parts' inventory required to ensure long term systems reliability for mechanical and HVAC systems.
• Site operations: Provide ongoing system ownership for site mechanical and HVAC systems operation and maintenance.
• Responsible for continuous improvement projects to drive operational efficiencies, reliability, and enhance safety.
• Own and maintain related drawings, schedules, zoning diagrams, and operating procedures for mechanical and HVAC systems.
• Work with electrical system owner to ensure electrical systems are working appropriately for mechanical and HVAC systems.
• Responsible to support electrical outages and HVAC system restarts to avoid impact to plant operations.
• Ensure plant readiness and Quality and Regulatory compliance for internal and external audits related to the Mechanical/HVAC systems.
• Collaborate with Amgen network sites to align and share good engineering practices for Mechanical/HVAC systems.
• Support trouble shooting and calibration activities for mechanical measurement and instrumentation (including validated humidity, temperature, and room differential pressure monitoring systems, as well as life safety gas detection systems).
• Ensure room pressurization strategy, control, testing, and documentation requirements for GMP classified manufacturing space are consistently maintained.
• Own and maintain HEPA/ULPA filter certification program, as well as certification of unidirectional booths, bio-safety cabinets, and fume hoods.
• As the system owner, provide recommendations on facility changes affecting mechanical and HVAC systems and support project implementation.
• Responsible for SLCM by working with Global Lifecycle Asset Management team to ensure system lifecycle are current and maintained.
• Work with original equipment manufacturers and integrated service providers for breakdown and planned maintenance.
• Provide rotational on-call support and ensure 24x7 day-to-day reliability of Mechanical/HVAC systems for plant operations.