Manufacturing Manager Programs – Cleaning Validation

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Amgen Inc. in North Carolina seeks a Manufacturing Manager for Cleaning Validation Live, leading validation strategy and master plans at ANC.

You will oversee autoclave performance qualification, cleaning validation, and validation maintenance, ensuring compliance with regulatory standards. The role requires building and directing a team, authoring and reviewing validation documents, and coordinating with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to meet Amgen

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
• 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

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

Skills

Leadership

Technical writing

Validation

Equipment qualification

Cleaning validation

Regulatory compliance

Education

PhD

MS in Engineering

BS in Engineering

Associates degree

High school diploma

Job description

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

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

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
• 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 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

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.

Salary Range

USD - USD Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.