Manufacturing Manager Programs – Cleaning Validation

What you will do

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, programs, or directing the allocation of 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 collaborate 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