Lead, Cleaning Validation Programs (Manufacturing)

Amgen Inc.; Holly Springs (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Amgen Inc. in Holly Springs, NC, seeks a Manufacturing Manager Programs for Cleaning Validation to lead the validation strategy at ANC.

You will develop and implement the Validation Master Plan, qualification protocols, and related reports, ensuring autoclave, cleaning validation, and validation maintenance milestones are met. The ideal candidate has advanced degrees and proven leadership in validation/engineering, with strong technical writing and regulatory experience.

Qualifications

• Doctorate or higher with Validation/Engineering experience.
• Experience managing people and/or leadership in teams or projects.
• Strong knowledge of validation concepts and regulatory expectations.

Responsibilities

• Lead a team implementing and maintaining the cleaning validation and sterilization program.
• Provide technical support for commissioning, qualification, cleaning validation, and maintenance.
• Collaborate with project leads on validation outputs for commissioning and qualification.
• Prepare and review cleaning characterization and related validation documents.
• Coordinate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development.
• Support regulatory filings, audits, and inspections; monitor validation status.

Skills

Leadership

Technical writing

Presentations

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Job description

Amgen Inc. in Holly Springs, NC, seeks a Manufacturing Manager Programs for Cleaning Validation to lead the validation strategy at ANC.

You will develop and implement the Validation Master Plan, qualification protocols, and related reports, ensuring autoclave, cleaning validation, and validation maintenance milestones are met. The ideal candidate has advanced degrees and proven leadership in validation/engineering, with strong technical writing and regulatory experience.