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.
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