Validation Engineer I — Lead Biotech Validation

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 86,000 - 116,000; Full time

Benefits offered by this job

Retirement and savings plan

Stock-based long-term incentives

Award-winning time-off plans

Flexible work models

Job summary

Amgen Inc. in North Carolina is seeking a Validation Engineer I to lead validation strategy development and execution at the ANC facility, including master plans, qualification protocols, and maintenance of validation status.

You will collaborate across Manufacturing, Engineering, Quality, and Process Development; support regulatory filings and audits; provide on-call support; and help drive continuous improvement in GMP-compliant operations.

Qualifications

• High school diploma or GED with 8 years manufacturing/operations experience.
• Associate’s degree with 6 years manufacturing/operations experience.
• Bachelor’s degree with 2 years manufacturing/operations experience.
• Master’s degree.

Responsibilities

• Lead development and implementation of the Validation strategy at the Amgen North Carolina facility.
• Develop and generate documents such as Validation Master Plan, validation plans, and equipment qualification reports.
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to meet validation requirements.
• Provide technical support for commissioning, qualification, cleaning/sterilization validation, and validation maintenance.
• Support regulatory filings, audits, and inspections; participate in continuous improvement initiatives.

Skills

Technical writing/presentation skills

Written/verbal communication

Project management experience

Interpersonal/facilitation skills

Analytical skills

Team-based collaboration

Education

High school diploma / GED with 8 years experience

Associate’s degree with 6 years experience

Bachelor’s degree with 2 years experience

Master’s degree

Tools

Kneat

CDOCs

Laboratory Inventory Management System

Pi

Job description

Amgen Inc. in North Carolina is seeking a Validation Engineer I to lead validation strategy development and execution at the ANC facility, including master plans, qualification protocols, and maintenance of validation status.

You will collaborate across Manufacturing, Engineering, Quality, and Process Development; support regulatory filings and audits; provide on-call support; and help drive continuous improvement in GMP-compliant operations.