Senior Process Engineer

Amgen SA; Holly Springs (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Annual bonus program

Stock-based incentives

Time-off plans and company shutdowns

Remote work arrangements

Job summary

Amgen is seeking a Senior Process Engineer to own biopharmaceutical process equipment from design through validation. You will collaborate with peers to ensure reliable plant operations and lead commissioning, qualification, and risk‑assessment activities in a GMP environment.

You will develop maintenance programs, manage spare parts, and provide on‑call support to maintain 24/7 reliability of upstream and downstream systems, while supporting audits and continuous improvement initiatives.

Qualifications

• PhD or Master’s with engineering experience required.
• Bachelor’s with 4+ years experience required.
• Associate’s with 8+ years experience required.
• HS diploma/GED with 10+ years experience required.

Responsibilities

• Provide system ownership for biopharmaceutical process equipment from design through validation.
• Collaborate with customers and support groups to ensure reliable plant operations.
• Develop maintenance programs, manage spare parts, and coordinate maintenance activities.
• Lead commissioning and qualification activities in a GMP environment.
• Provide rotational on‑call support to ensure 24/7 reliability of upstream and downstream systems.
• Lead risk assessments and support project execution.
• Ensure plant readiness for internal, external, and partner audits.

Skills

Root Cause Analysis

Statistical Process Control

Six Sigma

Predictive Maintenance

Communication

Teamwork

Education

PhD or Master’s +2y

Bachelor’s +4y

Associate’s +8y

HS diploma +10y

Tools

Cell culture reactors

Centrifugation

Chromatography

Filtration

CIP systems

Autoclaves

Utilities

Job description

Senior Process Engineer

• Provide system ownership for biopharmaceutical process equipment and support all phases from design through construction, startup, and validation.
• Collaborate with customers and support groups to ensure reliable plant operations.
• Develop maintenance programs, manage spare parts, and coordinate maintenance activities.
• Ensure all systems operate safely and comply with environmental, health, and safety practices.
• Lead commissioning and qualification activities in alignment with GMP requirements and interact with regulatory inspectors.
• Guide identification of performance risks and implement risk‑reduction strategies.
• Provide technical support to reduce production downtime through root‑cause analysis and corrective/preventive action.
• Support new product/technology introductions with engineering assessments, equipment modifications, and engineering runs.
• Provide rotational on‑call support to ensure 24/7 reliability of upstream and downstream systems.
• Lead new product/technology introductions, manage risk assessments, and support project execution.
• Ensure plant readiness for internal, external, and partner audits.

What we expect of you

• Doctorate degree, or Master’s degree with 2 years of engineering experience, or Bachelor’s degree with 4 years of experience, or Associate’s degree with 8 years of experience, or High school diploma/GED with 10 years of experience.
• Strong engineering background in biopharmaceutical operations with a focus on downstream unit operations.
• Experience designing, troubleshooting, and qualifying GMP biopharmaceutical production equipment and systems (e.g., cell culture reactors, centrifugation, chromatography, filtration, CIP systems).
• Proficiency in data‑driven techniques such as Root Cause Analysis, Statistical Process Control, Six Sigma, and Predictive Maintenance.
• Experience in regulated environments (cGMP, OSHA, EPA) and familiarity with GMP quality systems (change control, CAPA, validation).
• Knowledge of capital‑project lifecycle in a GMP setting, including procurement, construction, startup, and validation.
• Strong safety mindset and ability to navigate safety requirements.
• Excellent communication, facilitation, and teamwork skills.
• Independent, ambitious, and able to multi‑task in project environments.
• Prepared to travel domestically or internationally (≈10%).

Preferred Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering.
• 6+ years of relevant work experience, with 5+ years in biopharmaceutical manufacturing focusing on downstream unit operations.
• Direct knowledge of GMP biopharmaceutical equipment systems such as cell culture reactors, centrifugation, chromatography, filtration, autoclaves, CIP systems, and utilities.
• Ability to analyze problems and propose engineering solutions using scientific data analytics.
• Experience applying engineering principles to system modifications, new process introductions, and capital projects.
• Understanding of safety requirements in GMP biopharmaceutical production.
• Strong leadership, technical writing, presentation skills, and the ability to work in a team‑based environment.
• Work‑schedule flexibility, including willingness for 24/7 operations and occasional after‑hours coverage.

Benefits

• Comprehensive employee benefits package including retirement and savings plan with company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program and stock‑based long‑term incentives.
• Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
• Flexible work models, including remote work arrangements where possible.

Amgen is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.