Senior Specialist – Contamination Control and Investigations

Career Category

Manufacturing

Job 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 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 program s .

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

. Salary Range

137,263.10USD -185,708.90 USD