Holly Springs, North Carolina, United States · On-site
Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It…
Skills: Contamination Control, Microbiology, Sterility Assurance, Root Cause Analysis, Quality Risk Management
Holly Springs, North Carolina, United States · On-site
Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It…
Skills: People Management, Root Cause Analysis, CAPA Development, Environmental Monitoring, GMP
Holly Springs, North Carolina, United States · On-site
Career CategoryEngineeringJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with seriou…
Skills: Emerson DeltaV, Distributed Control System (DCS), Process Automation, Computerized Systems Validation, Data Integrity Assessments
Holly Springs, North Carolina, United States · On-site
Position Overview Oversee leave of absence programs to include FMLA; ADA; Pregnancy Worker’s Act; other federal, state, or local-mandated leave; and company leave. Provide operational oversight of third party leave vendo…
Skills: Leave of Absence Administration, FMLA Compliance, ADA Administration, Case Management, Workday LOA Module
Holly Springs, North Carolina, United States · On-site
$109k–$147k/yr
Career CategoryMaintenanceJob 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: Technical Leadership, Utility Operations, Maintenance Management, cGMP Compliance, Budget Management
Holly Springs, North Carolina, United States · On-site
$109k–$147k/yr
Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It…
Skills: HVAC Management, Electrical Systems, Utility Operations, People Management, Preventive Maintenance
Holly Springs, North Carolina, United States · On-site
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: Instrumentation & Controls, Automation Systems, Metrology, cGMP, FDA Regulations
Holly Springs, North Carolina, United States · On-site
$23/hr–$42/hr
You’ve invested a lot of time and energy in your education. Now you want the chance to make your mark. We offer challenging opportunities for you to learn and grow professionally. In our programs, you’ll be immersed in a…
Skills: Prescription Fulfillment, Patient Counseling, Immunization Administration, Drug Utilization Review, Pharmacy Operations
Holly Springs, North Carolina, United States · On-site
Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It…
Skills: Root Cause Analysis, Deviation Investigations, CAPA Development, Regulatory Inspection Readiness, GMP Compliance
Holly Springs, North Carolina, United States · On-site
Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It…
Skills: Root Cause Analysis, Quality Risk Management, CAPA Management, GMP Regulations, Technical Writing
Holly Springs, North Carolina, United States · On-site
$108k–$146k/yr
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: Upstream Manufacturing, Downstream Manufacturing, GMP Documentation, Root Cause Analysis, CAPA Implementation
Holly Springs, North Carolina, United States · On-site
$154k–$209k/yr
Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It…
Skills: People Leadership, Deviation Management, Root Cause Analysis, CAPA Management, Investigation Leadership
Holly Springs, North Carolina, United States · On-site
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: Sap, Erp Systems, Gmp Compliance, Cleanroom Operations, Inventory Control
Holly Springs, North Carolina, United States · On-site
$109k–$147k/yr
Career CategoryManufacturingJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serio…
Skills: Technical Leadership, GMP Maintenance, Planning and Scheduling, Troubleshooting, Reliability Improvement
Holly Springs, North Carolina, United States · On-site
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: Continuous Improvement, 5S Methodology, Lean Manufacturing, cGMP Compliance, Process Troubleshooting
Holly Springs, North Carolina, United States · On-site
$137k–$185k/yr
Career CategoryEngineeringJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious…
Skills: Emerson DeltaV, Process Control Network Design, Virtual Infrastructure, System Integration, OPC
Holly Springs, North Carolina, United States · On-site
$108k–$146k/yr
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: Project Management, Biologics Manufacturing, Technical Writing, Lean Manufacturing, Cross-functional Communication
Holly Springs, North Carolina, United States · On-site
$108k–$146k/yr
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: Project Management, Biologics Manufacturing, Technical Writing, Lean Manufacturing, Root Cause Analysis
Holly Springs, North Carolina, United States · On-site
$108k–$146k/yr
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: Project Management, Biologics Manufacturing, Downstream Processing, Technical Writing, Lean Manufacturing
Holly Springs, North Carolina, United States · On-site
Overview Allied Universal®, North America’s leading security and facility services company, offers rewarding careers that provide you a sense of purpose. While working in a dynamic, welcoming, and collaborative workplace…
Skills: Patrolling, Customer Service, Emergency Response, Incident Reporting, Access Control
Holly Springs, North Carolina, United States • On-site
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Lead complex contamination-related investigations and advance the site's Contamination Control Strategy within a biologics manufacturing plant. Coordinate cross-functional teams to identify risks, manage microbial excursions, and ensure inspection readiness for regulatory audits.
Requires a degree in Science or Engineering with experience ranging from 2 to 12 years depending on the education level. Preferred candidates have 7+ years of experience in biotechnology or pharmaceuticals with expertise in Annex 1, FDA, and EMA GMP requirements.
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
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 single use 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.
Senior Specialist – Contamination Control and Investigations
Live
What you will do
Let's do this. Let's change the world. In this vital role, you will serve as a key member of the team responsible for advancing the site's Contamination Control Strategy while leading complex contamination-related investigations within the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between GMP manufacturing teams and stakeholder groups including Microbiology, Process Development, Facilities & Engineering, Automation, EHSS, Manufacturing, and Quality.
This position is responsible for ensuring contamination risks are proactively identified, assessed, controlled, and continuously improved while leading high-impact investigations and supporting inspection readiness across the site.
Responsibilities include:
Manage complex contamination-related deviation investigations including microbial excursions, environmental monitoring events, utility excursions, aseptic process deviations, contamination events, and product quality investigations.
Represent the site in the Contamination Control Network and collaborate with network partners to align contamination control strategies, standards, lessons learned, and best practices while driving implementation of network initiatives and continuous improvement opportunities.
Provide technical leadership for contamination control-related audit and inspection responses, partnering with cross-functional teams to assess observations, develop risk-based remediation strategies, and ensure effective and sustainable corrective actions.
Support development, implementation, maintenance, and continuous improvement of the site's contamination control strategy.
Drive improvements to contamination control programs, contamination risk assessments, and investigation processes.
Lead contamination control inspection readiness activities and serve as a contamination control SME during regulatory inspections, internal audits, and management reviews.
Present contamination control strategies, investigation outcomes, and risk assessments to inspectors, auditors, and site leadership.
Perform trend analysis of environmental monitoring, utilities, contamination-related deviations, and quality events to identify emerging risks.
Coordinate and effectively lead cross-functional teams through complex contamination-related investigations and complete milestones on schedule.
Identify systemic contamination risks and drive site-wide corrective and preventive actions.
Partner with CCS network leads, QC Microbiology, Manufacturing, Engineering, Process Development, and Quality organizations to strengthen contamination prevention programs.
Apply advanced root cause analysis methodologies and quality risk management principles.
Navigate ambiguity and provide a structured, science-based problem-solving approach.
Develop metrics and tracking tools to ensure on-time closure of investigations and ongoing effectiveness of contamination control programs.
Mentor investigators and operational personnel on contamination control principles, contamination risk management, and investigation excellence.
Serve as a site SME for contamination control principles, contamination risk management, and contamination prevention strategies.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative professional we seek has a strong background in contamination control, microbiology, sterility assurance, manufacturing, investigations, and quality systems with demonstrated technical leadership and cross-functional collaboration skills.
Basic Qualifications:
Doctorate degree & 2 year of directly related experience
Or
Master's degree & 4 years of directly related experience
Or
Bachelor's degree & 6 years of directly related experience
Or
Associate's degree & 10 years of directly related experience
Or
High school diploma / GED & 12 years of directly related experience
Preferred Qualifications:
7+ years related work experience (microbiology, sterility assurance, manufacturing, process development, engineering, or quality assurance) in the biotechnology or pharmaceutical industry with progressively increasing responsibility.
Strong experience with contamination control programs, contamination risk management, investigations, quality systems, and compliance.
Degree in Science or Engineering. Microbiology studies or major a plus!
Experience developing, implementing, or maintaining contamination control strategies and contamination risk management programs.
Experience leading highly complex contamination-related investigations and performing contamination risk assessments to support quality and manufacturing operations.
Knowledge of Annex 1, FDA, EMA, and global GMP requirements related to contamination control and sterility assurance.
Experience using Veeva QMS for deviation investigations and CAPAs.
Experience presenting during regulatory inspections and internal audits.
Experience assessing and responding to contamination control-related audit or inspection observations and driving sustainable corrective actions.
Demonstrated project management ability.
Strong knowledge of environmental monitoring, utility monitoring, aseptic processing, and contamination prevention principles.
Excellent written and verbal communication skills.
Ability to work in a matrix environment and build strong cross-functional partnerships.
Strong interpersonal and technical leadership skills.
Thrive
What you can expect of us
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
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
#WeareBiotech
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. 🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines 🔗Global Privacy Statement Directory: www.amgen.com/dp 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
Based on 62 listings with disclosed salaries, most healthcare jobs in Holly Springs, NC pay between $71k–$156k per year. Individual offers vary with seniority, company size, and specialization.
There are currently 150 open healthcare positions in Holly Springs, NC listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Amgen, FUJIFILM Electronic Materials U.S.A., Inc., CSL, CVS Health, Roche, among others. Browse the listings above to see every active employer.
Yes — 7 of the 150 open healthcare positions offer remote or hybrid work (1 remote, 6 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
