Manufacturing Manager Programs – Cleaning Validation

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

Manufacturing Manager Programs - Cleaning Validation

Live

What you will do

Let’s do this. Let’s change the world. In this vital role the Senior Engineer-Validation will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance.

Responsibilities

• Lead a team responsible for implementing and maintaining the facility cleaning validation and sterilization program.
• Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC.
• Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment.
• Supply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents ( e.g., cleaning characterization/inactivation reports, acceptance limits reports).
• Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met.
• Furnish technical assistance and represent validation for regulatory filings, audits, and inspections.
• Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems.
• Support site/network validation driven continuous improvement initiatives.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 3 years of Validation or Engineering experience OR
• Bachelor’s degree and 5 years of Validation or Engineering experience OR
• Associate’s degree and 10 years of Validation or Engineering experience OR
• High school diploma/GED and 12 years of Validation or Engineering experience
• AND In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns , or directing the allocation or resources . Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications

• Experience managing staff executing technical skills in a safe and compliant manner.
• Proficient technical writing and presentations skills so as to collaborat e with technical and senior management staff
• Expertise in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facility
• Extensive experience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administration
• Involvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)
• Knowledge of Regulations Eudralex Annex 15, FDA Title 21 CFR Part 210 and 211, Guidelines ASTM E2500 and ICH Q7
• Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans

Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

Full support and career-development resources to expand your skills, enhance your expertise , and maximize your potential along your career journey.

A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.

Generous Total Rewards Plan— comprising health, finance and wealth, work/life balance, and career benefits, with compensation and benefits rated above 4 stars (out of 5) on Glassdoor.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Salary Range

USD - USD