Job Title: Manager Manufacturing, Single Use Systems & Validation
Location: Holly Springs, North Carolina, USA
Work Type: On-Site
Job ID: R-228425
Date Posted: October 22, 2025
Category: Manufacturing
Salary Range: USD 114,259 – 133,764 per year
About Amgen
At Amgen, every role contributes to a shared mission — to serve patients living with serious illnesses.
Since 1980, Amgen has pioneered the field of biotechnology, developing therapies across four main therapeutic areas:
Oncology
Inflammation
General Medicine
Rare Diseases
With a culture rooted in science, innovation, and collaboration, Amgen empowers professionals to make meaningful global impacts while growing their careers.
About the Facility
Join Amgen’s most advanced FleX Batch Drug Substance Manufacturing Facility in Holly Springs, NC.
This facility integrates:
Single-use technologies and traditional stainless-steel systems for maximum flexibility.
Industry 4.0 capabilities for intelligent, automated manufacturing.
Sustainability initiatives supporting Amgen’s goal to achieve carbon neutrality by 2027.
Position Overview
As Manager, Manufacturing (Single Use Systems & Validation), you will lead the Single Use Systems and Cleaning Validation Team within Amgen North Carolina’s GMP FlexBatch Manufacturing facility.
You will oversee the implementation, validation, and optimization of single-use technologies and equipment cleaning validation strategies, ensuring operational readiness, regulatory compliance, and process efficiency.
This position reports into the Manufacturing Support Organization and plays a key role in collaboration across Manufacturing, Process Development, Engineering, Supply Chain, and Quality.
Key Responsibilities
Leadership & Oversight
Manage the Single Use Systems & Cleaning Validation Team, providing technical direction, mentorship, and performance management.
Hire, train, and develop staff to ensure technical competency and GMP compliance.
Foster a culture of safety, innovation, and continuous improvement.
Technical Expertise
Serve as subject matter expert (SME) for single-use systems and cleaning validation in GMP biomanufacturing.
Lead the creation, review, and execution of:
Cleaning Validation Master Plans (CIP/SIP/COP)
Validation Plans, Equipment Qualification Protocols/Reports
SOPs and training materials related to single-use and cleaning operations
Drive resolution of technical challenges during commissioning, qualification, and start-up phases.
Compliance & Documentation
Ensure alignment with GMP, FDA, Eudralex Annex 15, ASTM E2500, and ICH Q7 regulatory standards.
Oversee preparation and maintenance of Quality Management System (QMS) records.
Support regulatory audits, submissions, and inspections.
Conduct risk assessments for equipment and processes, identifying mitigation strategies.
Operational Excellence
Promote Lean Transformation and Operational Excellence (OpEx) initiatives.
Lead continuous improvement efforts to enhance efficiency, safety, and compliance.
Collaborate cross-functionally to enable smooth technology transfers and new product introductions.
Ensure inspection readiness and provide leadership during internal/external audits.
Qualifications
Basic Qualifications
High School Diploma/GED + 12 years in biotech operations or validation OR
Associate’s Degree + 10 years of relevant experience OR
Bachelor’s Degree + 5 years of experience OR
Master’s Degree + 3 years of experience OR
Doctorate Degree
Preferred Qualifications
Degree in Chemical Engineering, Industrial Engineering, Biology, Biochemistry, Life Sciences, or related field.
Proven experience leading/managing teams in a GMP manufacturing setting.
Strong knowledge of Single Use Systems (SUS) and Cleaning Validation for biologics.
Experience supporting regulatory submissions, audits, and inspections.
Proficient in technical writing, data presentation, and cross-functional communication.
Demonstrated skills in project management, lean methodologies, and continuous improvement.
Ability to mentor, cross-train, and develop technical staff.
Working knowledge of FDA 21 CFR Part 210/211, Eudralex Annex 15, ASTM E2500, ICH Q7.
What Amgen Offers
Amgen supports your career growth and personal well-being through a comprehensive Total Rewards Plan including:
Competitive base salary and annual bonus opportunities
Health, dental, and vision insurance coverage
Retirement and savings programs with company contributions
Long-term stock-based incentives
Paid time off and wellness programs
Opportunities for career advancement, learning, and certification
A collaborative, inclusive workplace culture
Additional Information
Equal Opportunity Employer: All qualified applicants will be considered regardless of race, color, religion, gender, sexual orientation, gender identity, national origin, veteran, or disability status.
Accessibility: Reasonable accommodations are available for applicants with disabilities.
Application Link: careers.amgen.com
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