Contamination Control Process Owner — Advanced Biotech Manufacturing

NCBioImpact; Holly Springs (NC); On-site; USD 108,000 - 146,000; Full time

Job summary

Amgen North Carolina is seeking a Specialist Manufacturing – Contamination Control Process Owner to join the Manufacturing Support group. You will own contamination control processes, ensure CCS compliance, and support audits while coordinating with Site Lead and network for broader implications.

You will develop procedures for gowning, cleaning, material flow, and training, oversee CAPAs, and drive continuous improvement in aseptic operations and cleanroom behaviors within GMP manufacturing.

Qualifications

• Doctorate with 2 years of biotech operations experience or
• Master's degree with 4 years of biotech operations experience or
• Bachelor's with 6 years of biotech operations experience or
• Associate's with 10 years of biotech operations experience or
• High school diploma with 12 years of biotech operations experience

Responsibilities

• Own assigned contamination control processes and procedures.
• Implement CCS requirements and ensure audit readiness.
• Lead or contribute to process risk assessments and CAPAs.
• Oversee gowning, cleaning, material flow, and related training.

Skills

Technical writing

Communication

Problem solving

Organizational skills

Education

Doctorate degree

Master's degree in Engineering/Biology/Chemistry/Biochemistry

Bachelor's degree

Associate's degree

High school diploma

Job description

Amgen North Carolina is seeking a Specialist Manufacturing – Contamination Control Process Owner to join the Manufacturing Support group. You will own contamination control processes, ensure CCS compliance, and support audits while coordinating with Site Lead and network for broader implications.

You will develop procedures for gowning, cleaning, material flow, and training, oversee CAPAs, and drive continuous improvement in aseptic operations and cleanroom behaviors within GMP manufacturing.