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.
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- 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.
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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
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