Job Description Summary

As a Process Monitoring & Contamination Control Microbiologist, you will play a key role in protecting product quality and strengthening contamination control across our manufacturing operations. You will own the trending and interpretation of environmental monitoring data for filling lines, identify emerging risks, and drive risk-based improvements in line with EU GMP Annex 1 and the site Contamination Control Strategy. Bringing strong microbiological expertise, you will help ensure our monitoring, cleaning, disinfection, and contamination control practices remain robust, effective, and inspection-ready.

Job Description

Responsibilities

• Own the trending, review, and interpretation of environmental monitoring data for filling lines, including viable and non-viable particulate monitoring, identifying adverse trends and emerging contamination risks.
• Ensure environmental and particulate monitoring programmes, limits, sampling plans, escalation processes, and controls remain scientifically justified and aligned with EU GMP Annex 1 and the site Contamination Control Strategy.
• Drive risk-based improvements to monitoring programmes, processing controls, filling line practices, and contamination control governance.
• Provide microbiological expertise for the development, maintenance, and periodic review of the site Contamination Control Strategy.
• Review microbiological excursions, particulate monitoring events, and contamination control failures, ensuring robust root cause analysis, appropriate CAPAs, and effective follow-up.
• Review disinfectant efficacy, cleaning validation, and cleanroom disinfection practices to ensure controls remain effective, risk-based, and compliant with GMP requirements.
• Lead the annual review of the environmental monitoring programme, assessing its ongoing effectiveness, regulatory alignment, and suitability for classified and controlled manufacturing areas.
• Partner with QC, QA, Manufacturing, Engineering, and Regulatory teams to address monitoring trends, contamination risks, and continuous improvement opportunities.
• Act as a microbiology SME during audits and inspections, providing technical expertise on environmental monitoring, EU GMP Annex 1, and contamination control.
• Coach and support manufacturing, QC, and other teams to strengthen cleanroom discipline, contamination prevention behaviours, monitoring ownership, and overall contamination control capability.

Qualifications and Experience

• Degree in Microbiology, Biotechnology, or related scientific discipline.
• Strong experience in GMP microbiology, environmental monitoring, controlled manufacturing support, or contamination control.
• Strong expertise in:

• Particulate monitoring trending and interpretation

• Environmental monitoring and contamination control strategy EU GMP Annex 1 expectations for controlled manufacturing operations
• Disinfection, cleaning controls, and cleanroom contamination prevention

• Microbiological data review, investigations, RCA, and CAPA

• Proven ability to interpret monitoring data, identify adverse trends, and recommend risk-based actions.

• Experience supporting audits, inspections, quality improvements, and cross-functional contamination control initiatives.

 

Desirable skills

• Strong technical interpretation of microbiological and particulate monitoring data

• Risk-based problem solving and effective escalation

• Clear communication with QC, QA, Manufacturing, Engineering, and Regulatory stakeholders

• Ability to drive practical, inspection-ready improvements

• Strong regulatory awareness, attention to detail, and ownership mindset

 

Inclusion & Diversity
 

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.

Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

#LI-BG1
#LI-onsite

Additional Information