Biopharma Process Engineer: CIP/SIP & Autoclave (On-Site)

Amgen; Holly Springs (NC); Hybrid; USD 88,000 - 119,000; Full time

Job summary

Amgen in Holly Springs, NC is seeking a Process Engineer specialized in CIP/SIP and autoclave systems to join the Facilities & Engineering team. You will design, qualify, and own manufacturing systems for drug substance production while supporting startup readiness and regulatory readiness.

The role requires strong project execution, data-driven problem solving, and hands-on experience with biopharma equipment, ensuring Safety, Quality, and Compliance in a 24/7 manufacturing environment.

Qualifications

• Master’s degree in Chemical or Mechanical Engineering, or equivalent combination with required experience.
• Bachelor’s degree in Chemical or Mechanical Engineering with 2+ years of experience, or Associate’s degree with 6+ years, or high school diploma/GED with 8+ years.
• Experience in biopharmaceutical operations/manufacturing is preferred.
• Direct knowledge of GMP Biopharmaceutical Production facility equipment/systems including solution prep, upstream and downstream purification equipment.
• Ability to analyze problems and propose engineering solutions using data-driven techniques (RCA, SPC, Six Sigma).

Responsibilities

• Design, build, commission, and qualify new equipment and systems for drug substance production.
• Support commissioning and qualification of manufacturing systems per GMP and regulatory inspections.
• Provide lifecycle support for CIP skid systems, SIP circuits, autoclaves, transfer panels, process tanks, valves, instrumentation, and automation platforms.
• Develop maintenance programs and ensure spare parts availability.
• Support 24/7 operations and travel as needed.

Skills

GMP Biopharma ops

Data analytics

Root Cause Analysis

Six Sigma

Regulatory compliance

Communication & teamwork

Travel willingness

Travel willingness

Education

Master’s degree in Chemical or Mechanical Engineering

Bachelor’s degree in Chemical or Mechanical Engineering + 2 years experience

Associate’s degree in engineering + 6 years experience

High school diploma / GED + 8 years engineering experience

Tools

CIP systems

SIP circuits

Autoclaves

Process tanks

Valves & instrumentation

Job description

Amgen in Holly Springs, NC is seeking a Process Engineer specialized in CIP/SIP and autoclave systems to join the Facilities & Engineering team. You will design, qualify, and own manufacturing systems for drug substance production while supporting startup readiness and regulatory readiness.

The role requires strong project execution, data-driven problem solving, and hands-on experience with biopharma equipment, ensuring Safety, Quality, and Compliance in a 24/7 manufacturing environment.