Process Engineer - Solution Prep, Upstream, and Downstream

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen Inc. (IR) seeks a Process Engineer for Solution Prep, Upstream, and Downstream to partner with Facilities & Engineering to design, install, and qualify equipment for biopharmaceutical production. You’ll support commissioning, regulatory readiness, and ongoing operation readiness for manufacturing systems.

The role emphasizes problem-solving, data-driven improvements, and collaboration in a 24/7 setting, with travel as needed to support global plant operations.

Qualifications

• Engineering experience in regulated environments is preferred.
• Knowledge of GMP Biopharmaceutical production facilities is advantageous.
• Strong communication, leadership, and project management skills.

Responsibilities

• Support design, build, commission, and qualification of manufacturing systems for drug substance production.
• Provide 24/7 operations reliability support for Solution Prep, Upstream and Downstream systems.
• Lead risk assessment and implement corrective/preventive actions.
• Coordinate with regulatory inspectors and support validation activities.
• Travel up to domestic/international locations as required.

Job description

Process Engineer - Solution Prep, Upstream, and Downstream

Career Category Engineering Job Description 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.

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 domain expertise to support operations upon start-up. Site design, construction, start-up, and operational readiness: Support the commissioning and qualification of manufacturing systems in alignment with GMP requirements and interact with regulatory inspectors. Ensure systems are installed and operate safely and comply with pertinent environmental health/safety practice, rules and regulations. Support commissioning and qualification of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulations. Interact with regulatory inspectors as a manufacturing systems owner to communicate and demonstrate appropriate regulatory compliance of operating systems. Assist with new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs. Site Operations: Provide system support for biopharmaceutical process equipment. Assist in identifying and implementing engineering-based improvements or upgrades to equipment or facility systems. Support the development of business cases for improvements, identification of design requirements, and translation of these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of improvements. Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order. Provide system guidance to identify performance risks and implement risk reduction strategies. Provide problem solving support to reduce production downtime. This includes supporting technical root cause analysis and implementation of corrective/preventive action. Provide rotational on-call support and/or shift support based on business needs to ensure 24x7 day-to-day reliability of Solution Prep, Upstream and Downstream systems for plant operations. On-site and up to 10% domestic/international travel.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek enjoys challenges and is motivated to help serve patients with these qualifications.

Basic Qualifications

• Master’s degree OR Bachelor’s degree and 2 years of Engineering experience OR Associate’s degree and 6 years of Engineering experience OR High school diploma / GED and 8 years of Engineering experience

Preferred Qualifications

• Bachelor’ s degree in Chemical or Mechanical Engineering or similar engineer discipline.
• 3+ 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 equipment/systems with direct experience with Solution Prep, Upstream, and Downstream purification equipment such as weigh and dispense equipment, solution preparation vessels, cell culture reactors, centrifugation, chromatography, viral filtration skids, and UFDF skids 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range

. Salary Range 88,281.00USD -119,439.00 USD

Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen