Senior Process Engineer - Solution Prep, Upstream, and Downstream

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen Inc. seeks a Senior Process Engineer for Solution Prep, Upstream, and Downstream drug substance production.

You will partner with Facilities & Engineering to design, build, commission, and qualify equipment, ensuring systems meet GMP and safety standards. The role requires advanced degrees and extensive biopharmaceutical manufacturing experience, with a focus on process equipment, technology transfer, and CQV activities.

Qualifications

• Doctorate degree OR Master’s degree and 2 years of Engineering experience
• Bachelor’s degree and 4 years of Engineering experience
• Associate’s degree and 8 years of Engineering experience
• High school diploma / GED and 10 years of Engineering experience
• Degree in Chemical or Mechanical Engineering (preferred)

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Lead commissioning and validation to ensure regulatory compliance and readiness.
• Provide end-to-end support for Solution Prep, Upstream, and Downstream processes.
• Coordinate with Manufacturing, Quality, Process Development, and Maintenance for reliable operations.
• Develop maintenance programs and manage spare parts to keep systems ready.
• Travel up to 10% domestically/internationally.

Skills

Leadership

Communication

Teamwork

Problem-solving

Education

Doctorate degree

Master’s degree in Engineering

Bachelor’s degree in Engineering

Associate’s degree

High school diploma or GED

Tools

P&ID diagrams

GMP systems

QA/QC documentation

Job description

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.

Senior Process Engineer - Solution Prep, Upstream, and Downstream

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. This role will develop domain expertise and system ownership to support process operations, focusing on Solution Prep, Upstream, and Downstream Process engineering and plant equipment. Site design, construction, start-up, and operational readiness: Support the design and build of manufacturing equipment systems by aligning design review processes and documents with site requirements, including equipment design and sizing, architecture and electrical distribution, and piping and instrumentation diagrams. Support factory acceptance testing working in partnership with global engineering during site installation, including reviewing protocols and resolving punch list items. Work with capital project team to ensure systems are installed and operating safely and comply with pertinent environmental health/safety practice, rules and regulations as well as Amgen global engineering requirements. Ensure that systems are installed per the design requirements. Execute and guide the commissioning and validation of systems to ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Support execution of engineering and performance qualification runs while providing hypercare support as needed. Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required. Site Operations: Responsible system owner for Solution Prep, Upstream, and Downstream Drug substance process equipment, areas, and systems providing end-to-end support for operations. Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners) to ensure reliable plant operations. Work with original equipment manufacturers for breakdown and planned maintenance of process equipment as applicable. Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment. Develop master maintenance programs for equipment, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order. Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment. Provide technical mastery and problem-solving leadership to proactively reduce production downtime. This includes leading technical root cause analysis and implementation of corrective/preventive actions for families of systems. Lead new product/technology introductions by performing engineering assessments, equipment performance risk assessments, identifying gaps and owning their remediation, implementing equipment modifications, and supporting engineering runs. 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:

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

Preferred Qualifications:

• Degree in Chemical or Mechanical Engineering or similar engineering discipline.
• 6+ years' of relevant work experience with 5+ 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.
• Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
• 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
• 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.
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations.
• 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.

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.

Salary Range 115,494.60USD -156,257.40 USD

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