Senior CIP/SIP Process Engineer

Amgen

Holly Springs, NC

Shift: Full time

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.

SENIOR CIP/SIP PROCESS ENGINEER

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 OR Associate’s degree and 8 years 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 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 ann