Manufacturing Manager Programs – Cleaning Validation

Amgen • Holly Springs, NC

1d • Onsite

About The Position

Amgen is seeking a Manufacturing Manager Programs – Cleaning Validation to join their team at the Amgen North Carolina (ANC) manufacturing facility. This role will serve as a technical lead/subject matter expert (SME) responsible for developing and implementing the Validation strategy. The position involves creating documents such as the site’s Validation Master Plan, validation plans, and equipment qualification protocols/reports. The role is accountable for achieving milestones related to autoclave performance qualification, cleaning validation, and validation maintenance. This position is part of Amgen's newest and most advanced drug substance manufacturing plant, the FleX Batch facility, which combines disposable technologies with traditional stainless-steel equipment and integrates sustainability innovations.

Requirements

• 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.
• Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
• Managerial experience may run concurrently with the required technical experience.

Nice To Haves

• 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.

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.

Benefits

• 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 for a career that defies imagination.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed