Validation Engineer I, Biopharma Manufacturing

Biopharma Careers; Holly Springs (MS); On-site; USD 86,000 - 116,000; Full time

Job summary

Amgen’s North Carolina manufacturing facility seeks a Validation Engineer I to lead development and execution of the validation strategy for equipment and processes. You will generate Master Plans, qualification reports, and validation plans, ensuring GMP compliance and readiness for inspections.

The role requires strong technical writing, collaboration with Manufacturing, Engineering, Quality, and Process Development, and on-call support to maintain validated state and drive improvements across

Qualifications

• Bachelor’s or higher degree with 2+ years in manufacturing/operations per basic qualifications.
• Strong written and verbal communication skills; ability to collaborate with senior management.
• Experience in equipment qualification and cleaning validation preferred.

Responsibilities

• Lead development and implementation of validation strategy for ANC manufacturing.
• Prepare Validation Master Plan, validation plans, and qualification reports.
• Support regulatory filings, audits, and inspections with validation data.
• Maintain validation master plan and monitor regulatory compliance.
• Drive continuous improvement initiatives in validation processes.

Skills

Technical writing

Cross-functional collaboration

Project management

Regulatory readiness

Root cause analysis

Education

Bachelor’s degree

Master’s degree

Associate’s degree

High school diploma / GED

Tools

Kneat

CDOCs

Laboratory Inventory Management System

P.I.

Job description

Amgen’s North Carolina manufacturing facility seeks a Validation Engineer I to lead development and execution of the validation strategy for equipment and processes. You will generate Master Plans, qualification reports, and validation plans, ensuring GMP compliance and readiness for inspections.

The role requires strong technical writing, collaboration with Manufacturing, Engineering, Quality, and Process Development, and on-call support to maintain validated state and drive improvements across