Senior Engineer - Cleaning & Sterilization

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

Job summary

Amgen is seeking an ETA Senior Engineer - Cleaning & Sterilization Lead to provide engineering leadership for CIP/SIP systems across Amgen’s global network, with a focus on the ANC2 DS Facility project in North Carolina. You will design, start-up, commission, and support cleaning and sterilization equipment, including CIP/SIP skids, autoclaves, and associated circuits.

You will contribute to standards, troubleshooting, and digitalization initiatives while supporting maintenance practices.

Qualifications

• High school diploma / GED and 10 years of Engineering experience.
• Associate’s degree and 8 years Engineering experience.
• Bachelor’s degree and 4 years of Engineering experience.
• Master’s degree and 2 years of Engineering experience.
• Doctorate degree in a related field.

Responsibilities

• CIP/SIP engineering lead for ANC2 DS Facility Project.
• Support design of cleaning & sterilization equipment for capital projects.
• Provide CIP/SIP expertise to Operations network and partners.
• Troubleshoot emergent events to prevent recurrence across the network.
• Translate business needs into engineering technology solutions.
• Publish and maintain Engineering Standards and Specifications.
• Review performance data and recommend system improvements.
• Develop business cases for project proposals.
• Collaborate with design teams and external consultants on project plans and equipment selection.
• Investigate and deploy new technology; optimize total equipment life cycle.
• Advance digitalization tools for cleaning systems and engineering efforts.
• Support development of maintenance standards and techniques.
• Travel up to 30%.

Skills

Engineering experience

Process engineering

Regulated environment

Cross-functional collaboration

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Doctorate degree

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

ETA SENIOR ENGINEER - CLEANING & STERILIZATION LEAD

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide engineering leadership and technical expertise for the planning, design, construction, start-up, and operational support of Drug Substance Cleaning & Sterilization systems across Amgen’s global manufacturing and development network. The role will focus on Clean-in-Place (CIP), Steam-in-Place (SIP), caustic cleaning, and related cleaning and sterilization technologies. The Senior Engineer will be a member of the Engineering Technical Authority (ETA) on the Drug Substance Process Engineering team. ETA provides global technical direction, leadership, guidance, and engineering support for process systems throughout Amgen’s manufacturing and development network. In this role, you will support initiatives that deliver robust, reliable, and standardized cleaning and sterilization capabilities across the network. The immediate focus of this role will be supporting the Amgen North Carolina 2 (ANC2) Capital Project. The Senior Engineer will be responsible for the successful design, construction, commissioning, and start-up of the facility’s cleaning and sterilization scope. Key systems and responsibilities will include three CIP skids and their associated cleaning circuits, plant-wide SIP operations, downstream caustic cleaning operations, and glass wash and autoclave systems. Beyond ANC2, the role will provide ongoing technical support to Amgen’s global network, including troubleshooting and resolution of emergent operational issues, continuous improvement initiatives, and engineering support for future capital projects.

• CIP/SIP Engineering lead for ANC2 DS Facility Project.
• Support design of cleaning & sterilization equipment related to capital projects across the Amgen network.
• Provide CIP/SIP related expertise to our Operations network and partners.
• Assist sites in troubleshooting, and remediation of emergent events to prevent future occurrence throughout the network.
• Translate business needs into engineering technology solutions.
• Publish and maintain Engineering Standards and Specifications.
• Review performance data and recommend improvements for systems.
• Facilitate the business case development of project proposals.
• Work with project design teams and external consultants to craft, develop, and support engineering project development, plans, standards, and equipment selection.
• Investigate and deploy new technology.
• Ensure designs optimize the total equipment life cycle.
• Advance digitalization tools for optimization of cleaning systems and other engineering efforts.
• Support development of maintenance standards and techniques.
• Travel up to 30%.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a collaborative individual with these qualifications.

Basic Qualifications

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

Preferred Qualifications

• Professional registration, such as a Professional Engineer (PE) license or equivalent OR on route to getting it.
• Certified Energy Manager (CEM) qualification is an advantage
• Familiarity and/or experience working in a regulated environment, pharmaceutical or biotechnology industries or electronics.
• Strong communication skills (both written and oral)

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, 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.

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