Senior Engineer - Cleaning & Sterilization

Biopharma Careers; Holly Springs (MS); On-site; USD 115,000 - 156,000; Full time

Job summary

Amgen is seeking a Senior Engineer for Cleaning & Sterilization to lead CIP/SIP initiatives and support the ANC2 DS Facility Project. You will ensure robust, compliant cleaning and sterilization processes across Amgen’s global network.

The role requires engineering leadership, experience with regulated environments, and strong communication skills as you collaborate with cross-functional teams and external consultants. Travel up to 30% is anticipated.

Qualifications

• Requires at least a high school diploma/GED with 10 years of engineering experience, OR an associate degree with 8 years, OR a bachelor’s degree with 4 years, OR a master’s degree with 2 years, OR a doctorate.
• Experience in regulated environments and pharmaceutical/biotechnology industries is preferred.
• Professional communication skills, both written and oral, are important.

Responsibilities

• Lead CIP/SIP engineering activities for ANC2 DS Facility Project.
• Assist design of cleaning & sterilization equipment for capital projects across the Amgen network.
• Provide CIP/SIP expertise to Operations and partners.
• Troubleshoot and remediate emergent events to prevent recurrence across the network.
• Develop and maintain engineering standards and specifications.
• Review performance data and recommend improvements for systems.
• Support business case development for project proposals.

Skills

Engineering experience

Regulatory environment familiarity

Strong communication skills

Education

Bachelor’s degree in Engineering

Master's degree in Engineering

Doctorate degree

Job description

Career Category

Engineering

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission, to serve patients, drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Title

Senior Engineer - Cleaning & Sterilization

Live

What you will do

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.

Responsibilities

• 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. Ensuring 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 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

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 our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range

115,494.60USD -156,257.40USD