Senior Process Engineer - Clean Utilities (Biopharmaceutical Production)

Amgen; Holly Springs (NC); On-site; USD 119,000 - 148,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Senior Process Engineer for Clean Utilities. This role involves designing and qualifying systems for drug production, ensuring compliance with GMP standards, and leading engineering improvements. Candidates should have a strong engineering background and relevant experience in biopharmaceutical manufacturing.

Benefits

Health plans

Retirement plans

Bonuses

Stock incentives

Flexible work arrangements

Qualifications

• Master’s degree with 3 years or Bachelor’s with 5 years of engineering experience.
• Knowledge of GMP systems like autoclaves, CIP, and clean steam.
• Experience in regulated environments (cGMP, OSHA, EPA).

Responsibilities

• Design, build, and qualify new equipment and systems for drug substance production.
• Develop maintenance programs and ensure spare parts availability.
• Complete commissioning and qualification of systems in line with GMP requirements.

Skills

Data-driven problem-solving

Leadership

Teamwork

Education

Master’s degree in Engineering

Bachelor’s degree in Chemical or Mechanical Engineering

Associate’s degree in Engineering

High school diploma/GED

Tools

GMP systems

Six Sigma

Job description

Senior Process Engineer - Clean Utilities (Biopharmaceutical Production)

Join to apply for the Senior Process Engineer - Clean Utilities (Biopharmaceutical Production) role at Amgen.

This range is provided by Amgen. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$119,195.00/yr - $147,867.00/yr

Job Description

Senior Process Engineer - Clean Utilities

What you will do

In this vital role, you will join the Facilities & Engineering (F&E) group to collaborate with the corporate engineering team. Your responsibilities include designing, building, commissioning, and qualifying new equipment and systems for drug substance production, as well as developing domain expertise to support operations during startup.

1. Provide system ownership for biopharmaceutical process equipment. Support, lead, and implement engineering improvements or upgrades, including developing business cases, translating requirements into design, and supporting construction, startup, and validation.
2. Develop maintenance programs, ensure spare parts availability, and coordinate activities to maintain system functionality.
3. Ensure systems are installed and operated safely, complying with environmental health and safety regulations.
4. Complete commissioning and qualification of systems in line with GMP requirements and liaise with regulatory inspectors.
5. Identify performance risks and implement strategies to mitigate them.
6. Support troubleshooting to minimize production downtime, including root cause analysis and corrective actions.
7. Assist with new product/technology introductions through engineering assessments and modifications.

What we expect of you

We value diverse contributions and seek candidates who enjoy challenges and are motivated to serve patients.

Basic Qualifications:

• Master’s degree with 3 years of engineering experience, or
• Bachelor’s degree with 5 years of engineering experience, or
• Associate’s degree with 10 years of engineering experience, or
• High school diploma/GED with 12 years of engineering experience.

Preferred Qualifications:

• Bachelor’s in Chemical or Mechanical Engineering.
• 6+ years of relevant experience, including 5+ years in biopharmaceutical manufacturing.
• Knowledge of GMP systems such as autoclaves, CIP, washers, clean steam, water for injection.
• Data-driven problem-solving skills, including RCA, SPC, Six Sigma, predictive maintenance.
• Experience in regulated environments (cGMP, OSHA, EPA) and quality systems.
• Engineering expertise in system modifications, process implementation, and capital projects.
• Understanding of GMP biopharmaceutical facility projects from procurement to validation.
• Strong communication, leadership, and teamwork skills.
• Flexibility for 24/7 support and travel.

What you can expect from us

We support your professional growth through competitive benefits, including health plans, retirement plans, bonuses, stock incentives, time off, and flexible work arrangements.

Join Amgen’s Mission of Serving Patients

Our mission is to serve patients with serious illnesses. Since 1980, we've pioneered biotech innovations across Oncology, Inflammation, General Medicine, and Rare Diseases, impacting millions of lives annually.

Our culture is collaborative, innovative, and science-driven. If you thrive on challenges, join us to make a difference and advance your career.

Apply now

for a career that defies imagination. Visit careers.amgen.com to apply. We accept applications until the position is filled.

Amgen is committed to diversity and inclusion, providing accommodations for applicants with disabilities. We are an Equal Opportunity employer, considering all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.