Senior Process Engineer

Amgen•Holly Springs, NC

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives 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 Process Engineer What you will do Let’s do this. Let’s change the world. 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 domain expertise to support operations upon start up. Provide system ownership for Biopharmaceutical process equipment. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment. Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order. Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations. Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors. System guidance to identify performance risks and implement risk reduction strategies. Providing problem solving support to reduce production downtime. This will involve 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.

Requirements

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

Nice To Haves

Bachelor’s degree in Chemical or Mechanical Engineering
6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment with a focus on Upstream unit operations
Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, centrifugation, chromatography, tangential flow filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
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 the oversight of capital projects
Understanding 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
Collaborative teammate prepared to work in and embrace a team based environment that relies on communication 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 (~10%)

Responsibilities

Provide system ownership for Biopharmaceutical process equipment.
Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the equipment or facility systems.
Develop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance activities to ensure systems are in proper working order.
Ensure systems are installed and operating safety and stay in sync with pertinent environmental health/safety practice, rules and regulations.
Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors.
System guidance to identify performance risks and implement risk reduction strategies.
Providing problem solving support to reduce production downtime.
Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.