Manufacturing Training Specialist – Manufacturing Support
Holly Springs, North Carolina, United States · On-site
$108k–$146k/yr
Senior$29B raised
Career CategoryManufacturingJob 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…
Skills: Training Development, Biotechnology Operations, LMS Management, GMP Compliance, CAPA
Holly Springs, North Carolina, United States · On-site
Mid level
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Holly Springs, North Carolina, United States · On-site
Senior
Duke Neurology is seeking a board eligible/board certified Neurologist with Headache fellowship training to join its expanding outpatient neurology practice in the rapidly growing Raleigh-Durham, NC area. See patients in…
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CTE - Career Academy, Career Development Coordinator, Part-Time
Holly Springs, North Carolina, United States · On-site
Mid level
Overview POSITION TITLE (Oracle title) CAREER ACADEMY-CAREER DEVELOPMENT COORDINATOR WORKING TITLE Career Academy Coordinator SCHOOL/DEPARTMENT High School/Career and Technical Education LOCATION High School PAY GRADE Te…
Skills: Microsoft Office, Google Apps, Leadership, Team Building, Interpersonal Skills
Holly Springs, North Carolina, United States · On-site
Entry level
Overview POSITION TITLE (Oracle title) INSTRUCTIONAL ASSISTANT WORKING TITLE Instructional Assistant (IA) SCHOOL/DEPARTMENT Elementary, Middle, or High School LOCATION School Site PAY GRADE Noncertified Grade 20 FLSA STA…
Skills: Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Google Apps, Instructional Delivery
Holly Springs, North Carolina, United States · On-site
$40/hr–$70/hr
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InstaSwim is looking to hire professional and experienced private swim instructors to teach swim lessons in our clients private homes & community pools all within your location & surrounding cities! We supply the clients…
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Holly Springs, North Carolina, United States · On-site
$35/hr–$50/hr
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Earn up to $50 per lesson coaching lacrosse on your schedule STXZ is hiring experienced lacrosse coaches to join the nation's #1 private lacrosse training marketplace. You run your own independent coaching business, we b…
Skills: Lacrosse Coaching, Player Development, Communication, Lesson Planning, Youth Athletics
Holly Springs, North Carolina, United States · On-site
$15/hr–$16/hr
Entry level
No nights and weekends! We are looking for a Infant/Toddler assistant teachers (part-time ) to join our team today. If you have experience working with children, we’d love to talk to you about a career in early childhood…
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Holly Springs, North Carolina, United States · On-site
$16/hr–$18/hr
Entry level
Benefits: No nights and weekends Childcare discounts Recognition programs Professional development and CDA tuition reimbursement Tuition reimbursement 401(k) Competitive salary Dental insurance Health insurance Paid time…
Holly Springs, North Carolina, United States · On-site
$16/hr–$21/hr
Entry level
Benefits: Free uniforms Health insurance Paid time off Training & development Vision insurance 401(k) matching Bonus based on performance Competitive salary Dental insurance Employee discounts Free food & snacks Tuition …
Skills: Communication, Customer Service, Problem Solving, Student Guidance, Classroom Management
Special Education Teacher - Elementary Behavior Support II, Track 4
Holly Springs, North Carolina, United States · On-site
Mid level
Overview POSITION PURPOSE: Coordinates and provides direct instructional programs relating to special education students and their Individual Education Programs (IEPs). Monitors and evaluates programs with students with …
Holly Springs, North Carolina, United States · On-site
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Overview The Physician Assistant (PA) or Nurse Practitioner (NP) will work under the general supervision of their Medical Director all physician partners and their APP Manager in WakeMed Physician Practices to deliver co…
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Holly Springs, North Carolina, United States · On-site
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Overview POSITION PURPOSE: Plans and provides for appropriate classroom learning experiences for students. Provides an atmosphere and environment conducive to the intellectual, physical, social and emotional development …
Elementary School Teacher - Instructional Coach Part Time - 50%
Holly Springs, North Carolina, United States · On-site
Mid level
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Elementary School Teacher - Instructional Coach, Part Time - 50%
Holly Springs, North Carolina, United States · On-site
Mid level
Overview POSITION PURPOSE: Plans and provides for appropriate classroom learning experiences for students. Provides an atmosphere and environment conducive to the intellectual, physical, social and emotional development …
Holly Springs, North Carolina, United States · On-site
Mid level
Overview POSITION PURPOSE: Plans and provides for appropriate classroom learning experiences for students. Provides an atmosphere and environment conducive to the intellectual, physical, social and emotional development …
Instructional Assistant - Special Education, Special Assignment
Holly Springs, North Carolina, United States · On-site
Entry level
Overview POSITION TITLE (Oracle title) INSTRUCTIONAL ASSISTANT-SPECIAL EDUCATION WORKING TITLE Special Education Instructional Assistant-General Curriculum Special Education Instructional Assistant-Adapted Curriculum Spe…
Skills: Microsoft Office, Google Apps, Instructional Delivery, Classroom Management, Student Motivation
Holly Springs, North Carolina, United States · On-site
Entry level
Overview POSITION PURPOSE: Plans and provides for appropriate classroom learning experiences for students. Provides an atmosphere and environment conducive to the intellectual, physical, social and emotional development …
Holly Springs, North Carolina, United States · On-site
Senior+
Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facil…
Skills: Current Good Manufacturing Practice, Aseptic Qualifications, Training Facilitation, SAP, Change Management
Holly Springs, North Carolina, United States · On-site
Entry level
Overview POSITION PURPOSE: Plans and provides for appropriate classroom learning experiences for students. Provides an atmosphere and environment conducive to the intellectual, physical, social and emotional development …
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$108k–$146k/yr
Full-time
high school, associate degree, bachelor degree, postgraduate degree
Posted 7d ago
~40 hrs/week
Responsibilities
Lead the manufacturing training strategy and workforce readiness for the ANC-1 and ANC-2 facilities to ensure safe and compliant operations. Provide technical leadership and floor-level coaching to enhance training effectiveness and operational excellence.
Requirements
Requires a degree in chemistry, biology, or engineering with corresponding years of biotechnology operations experience (ranging from 3 to 12 years depending on education level). Preferred qualifications include experience with LMS, SOP development, and deviation management systems.
Full 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 Training Specialist – Manufacturing Support
The Manufacturing Training Specialist 5 serves as a senior individual contributor within the Manufacturing Support organization, providing technical leadership and operational support to ensure safe, compliant, and efficient manufacturing training operations across the site, with clear accountability for manufacturing workforce readiness and startup readiness outcomes.
Reporting to the Senior Manager of the MFG Support technical training team, this role serves as a site subject matter expert for manufacturing training processes, training effectiveness, and continuous improvement programs. The position requires significant floor presence and broad partnership with Manufacturing, Quality, Engineering, Supply Chain, HR, and Continuous Improvement teams to drive training readiness, operational performance, and quality improvement in a 24/7 manufacturing environment.
Organizational Impact
The Manufacturing Training Specialist 5 is a technical leader who strengthens manufacturing capability, enhances training effectiveness, and advances operational excellence across the organization. Through cross-functional collaboration, ownershipof qualification planning and execution, readiness metric governance, and leadership of training-related CAPAs and continuous improvement initiatives, this role directly supportsANC-1 and ANC-2 startup readiness, operational readiness milestones, andthe delivery of high-quality medicines to patients.
Key Responsibilities
Training and Capability Development
Develop and execute the manufacturing training strategy for ANC-1 and ANC-2, ensuring alignment with businessobjectives, operational readiness requirements, compliance expectations, and workforce capability needs.
Create, implement, and continuously mature the Training Assignment Portfolio (TAP) for ANC-1 and ANC-2 toestablishrole-based qualification pathways,own qualification planning and execution,improve training effectiveness, and support sustainable operational performance.
Develop andmaintaintrainingand workforcereadiness governance tools, metrics, and reporting processes tomonitortraining compliance, qualification status,staffing readiness, procedural readiness, and overall manufacturing startupreadiness.
Identifyreadiness risks and gaps through metric review, stakeholder input, and floor engagement, then drive mitigation actions to protect operational readiness milestones, engineering runs, validation execution, and startup commitments.
Escalate and resolve issues when training, qualification, staffing, procedures, or other manufacturing readiness deliverables threaten startup milestones or operational readiness commitments.
Strengthen alignment between hiring plans, qualification plans, readiness milestones, engineering runs, and validation execution to ensure the manufacturing workforce is prepared to support ANC-2 startup and routine operations.
Lead Manufacturing Fundamentals Training programs to support onboarding and qualification of new hires within the ANC-1 and ANC-2 organizations, ensuring consistent foundational knowledge and accelerated readiness.
Serve as the training lead for the 2027 Learning Management System (LMS) migration, partnering with cross-functional stakeholders to support planning, implementation, change management, training impact assessments, and successful adoption of the new platform.
Lead training improvement initiatives across manufacturing operations.
Own and implement training-related corrective and preventive actions (CAPAs), ensuringtimelyexecution, effectiveness monitoring, and sustained compliance.
Assess training effectiveness andidentifyopportunities to strengthen workforce capability, procedural adherence, and operational performance.
Develop and deliver technical training programs, including the Wake Tech Customized Training Program, to improve employee knowledge, capability, and performance.
Coach manufacturing personnel and frontline leaders on GMP compliance, operational excellence practices, and manufacturing best practices.
Partner with Manufacturing, Quality, Engineering, and Continuous Improvement teams toestablishand maintain training curricula that support process changes, operational excellence initiatives, and inspection readiness.
Manufacturing Floor Leadership
Maintain a strong presence on the manufacturing floor to providetrainingsupport, coaching, andtechnicalassistanceto frontline teams and leaders.
Serve as a subject matter expert for LMS and training-related processes in manufacturing.
Partner with operations teams toidentifyand implementtrainingimprovements that enhance safety, quality, delivery, and productivity.
Drive right-first-time execution throughHuman and Organizational Performance (HOP) toolsand collection of operator feedback.
Cross-Functional Leadership
Partner effectively with Quality, Engineering, Validation, Supply Chain,HR,and Manufacturing teams to achieve siteobjectivesandmaintainintegrated readiness plans that connect staffing, training, qualification, procedure readiness, engineering runs, and validation activities.
Influence stakeholders at multiple organizational levels to drive alignment, resolve issues, and implement sustainable solutions.
Serve as a key Manufacturing representative within ANC-2 Operational Readiness governance and planning activities, ensuring manufacturing workforce readiness, qualification execution, and startup risks are visible, aligned, and actively managed.
Provide data-driven recommendations, readiness metric insights, and risk-based mitigation optionsto support business decisions, issue resolution,and operationalreadiness governance.
Basic Qualifications:
Doctorate degree OR
Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or
Bachelor’s degree and 5 years of biotechnology operations experience or
Associate’s degree & 10 years of biotechnology operations experience or
High school diploma / GED & 12 years of biotechnology operations experience
Preferred Qualifications:
• Hands on experience facilitating problem solving in a biotechnology environment • Experience with training development and facilitation • Experience owning and editing standard operating procedures • Familiarity with the deviation management systems and corrective/preventative actions • Project management skills with ability to multi-task and function in a dynamic environment • Excellent communication skills and sense of urgency • Demonstrated ability to forge and maintain strong relationships
Strong knowledge of Learning Management Systems (LMS)
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
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 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 accommodation.
#AmgenNorthCarolina
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Salary Range
107,545.40USD -145,502.60 USD
Related keywords
BiotechnologyDrug Substance ManufacturingLMSGMPCAPAOperational ReadinessSOPHuman and Organizational PerformanceHOPIndustry 4.0ValidationQualification PlanningTraining Assignment PortfolioTAPManufacturing Support
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
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Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
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