Manufacturing Manager Programs - Cleaning Validation
- Location
- Holly Springs, NC
- Listed
- 3 days ago
About the role
Career Category
Manufacturing
About the role
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.
About the role
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
- Win
- 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
- Apply now for a career that defies imagination
- Objects in your future are closer than they appear careers.amgen.com
- #AmgenNorthCarolina
Salary Range
USD - USD
Equal opportunity and legal notices
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..
From Amgen's careers page, first listed on Rolev.ai on November 6, 2026. Rolev.ai is not the employer.
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Common questions
Where is the Manufacturing Manager Programs - Cleaning Validation job at Amgen located?
This Manufacturing Manager Programs - Cleaning Validation position at Amgen is located in Holly Springs, NC. Always check Amgen's application page for specific state eligibility or relocation policies.
How do I apply for the Manufacturing Manager Programs - Cleaning Validation position at Amgen?
This listing links directly to Amgen's Workday application page. You can apply directly on Amgen's site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the Workday application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.