Validation Engineer I — GMP Equipment Qualification Lead

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

Job summary

Amgen is seeking a Validation Engineer I to lead development and execution of validation strategies at the Amgen North Carolina facility. You will oversee Validation Master Plan, qualification protocols, and reports, while coordinating cleaning/sterilization validation and regulatory filings.

The role requires strong technical writing, cross-functional collaboration, and the ability to work across manufacturing, quality, and process development teams to meet GMP requirements and drive

Qualifications

• Proven ability to work in cross-functional teams.
• Strong technical writing and presentation skills.
• Ability to analyze complex problems and provide solutions.

Responsibilities

• Lead development and implementation of validation strategy for ANC manufacturing facility.
• Develop Validation Master Plan, validation plans, equipment qualification protocols/reports.
• Coordinate cleaning/sterilization validation activities and regulatory support.
• Provide technical support for commissioning, qualification, and maintenance of process equipment.
• Interact with multiple functions to ensure GMP/compliance and continuous improvement.

Education

High school diploma / GED

Associate’s degree

Bachelor’s degree

Master’s degree

Job description

Amgen is seeking a Validation Engineer I to lead development and execution of validation strategies at the Amgen North Carolina facility. You will oversee Validation Master Plan, qualification protocols, and reports, while coordinating cleaning/sterilization validation and regulatory filings.

The role requires strong technical writing, cross-functional collaboration, and the ability to work across manufacturing, quality, and process development teams to meet GMP requirements and drive