Manufacturing Manager Programs – Cleaning Validation

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’veworked 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, experienceand 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 patientsworldwide. 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 FleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleXBatch 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’schange the world. In this vital rolethe 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 forimplementing and maintainingthefacility cleaning validation and sterilizationprogram.

• Provide technical support and domain expertisefor 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 expertiseincluding 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

• Furnishtechnical assistanceand 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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seekwill possessthese qualifications.

Basic Qualifications

Doctorate degree OR

Master’s degree and 3years of Validationor EngineeringexperienceOR

Bachelor’s degree and 5years 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 orresources. Your managerial experience may run concurrently with the required technical experience referenced above

PreferredQualifications

• Experience managing staff executing technical skills in a safe and compliant manner.

• Proficient technical writing and presentations skills so as tocollaboratewith technical and senior management staff

• Expertisein 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 EudralexAnnex 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-comprisinghealth, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear

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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 reasonableaccommodation to participatein 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 withapplicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis ofa medical reason or a sincerely heldreligious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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