ETA Senior Engineer - Cleaning & Sterilization Lead

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Benefits package

Flexible work models

Retirement and savings plan

Job summary

Amgen in North Carolina is seeking an ETA Senior Engineer - Cleaning & Sterilization Lead to provide engineering leadership for CIP/SIP, caustic cleaning, and related cleaning and sterilization systems across the global manufacturing and development network. The role focuses on ANC2 DS Facility and will design, construct, commission, and start-up cleaning systems, with travel up to 30%.

Ideal candidates will have senior engineering experience in regulated environments, PE licensure or progress

Qualifications

• High school diploma / GED and 10 years of Engineering experience OR
• Associates degree and 8 years Engineering experience OR
• Bachelors degree and 4 years of Engineering experience OR
• Masters degree and 2 years of Engineering experience OR
• Doctorate degree

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 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%.

Skills

Leadership

Regulatory experience

Written and verbal communication

Team collaboration

Problem solving

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Doctorate degree

Associate degree

High school diploma / GED

Tools

Professional Engineer license

Job description

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this. Lets 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 Amgens 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 Amgens 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 facilitys 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 Amgens 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
• Associates degree and 8 years Engineering experience OR
• Bachelors degree and 4 years of Engineering experience OR
• Masters 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, well 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.

careers.amgen.com

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.