Associate Principal Scientist, Microbiology Testing, EM/Utilities Monitoring Program – Onsite/First Shift
Merck
June 29, 2026
On-site
Rahway, NJ
Operations
Primary Responsibilities:
- Lead execution of GMP microbiology finished product testing, utilities, and environmental monitoring (EM) program.
- Serve as QC microbiology SME for sterile operations (isolator qualifications, sterility testing, biological indicator challenges, method suitability, endotoxin, microbial enumeration, media/reagent QC, mycoplasma).
- Design/execute aseptic special studies; author and trend EM/utilities reports.
- Build and maintain a scientifically sound, risk-based, inspection-ready microbiology/EM/utilities program integrating EM and product testing into contamination control strategy.
- Analyze EM/water-system trends; identify hotspots and systemic/personnel risks; recommend and implement risk-based mitigations.
- Execute studies to ALCOA/data integrity; conduct test method suitability; support release/stability testing for small molecule, biologic, and vaccines.
- Troubleshoot and lead investigations, CAPAs, and change controls for GMP testing/monitoring; coordinate with cross-functional Quality stakeholders.
- Supervise microbiology team, data review, equipment, inventory; oversee contract lab studies; support internal/external audits.
Education Minimum Requirements:
- PhD + 4 years pharma experience; or MS + 8 years; or BS in Microbiology/related Biological Sciences + 12 years.
Required Experience/Skills:
- GMP microbiology testing expertise; EM program leadership aligned with EU GMP Annex 1.
- Risk-based EM strategy design; EMPQ, requalification, periodic review; EM data trending/statistics (e.g., MODA).
- Knowledge of aseptic manufacturing, contamination control, quality investigations, audits, and current regulatory/industry guidance.
Preferred Skills:
- Testing in clean room environments; aseptic process validation.
- MODA, SAP, Veeva, LIMS.
Application:
- Apply at https://jobs.merck.com/us/en. Application deadline stated on posting (Job posting end date: 07/6/2026).
- Lead execution of GMP microbiology finished product testing, utilities, and environmental monitoring (EM) program.
- Serve as QC microbiology SME for sterile operations (isolator qualifications, sterility testing, biological indicator challenges, method suitability, endotoxin, microbial enumeration, media/reagent QC, mycoplasma).
- Design/execute aseptic special studies; author and trend EM/utilities reports.
- Build and maintain a scientifically sound, risk-based, inspection-ready microbiology/EM/utilities program integrating EM and product testing into contamination control strategy.
- Analyze EM/water-system trends; identify hotspots and systemic/personnel risks; recommend and implement risk-based mitigations.
- Execute studies to ALCOA/data integrity; conduct test method suitability; support release/stability testing for small molecule, biologic, and vaccines.
- Troubleshoot and lead investigations, CAPAs, and change controls for GMP testing/monitoring; coordinate with cross-functional Quality stakeholders.
- Supervise microbiology team, data review, equipment, inventory; oversee contract lab studies; support internal/external audits.
Education Minimum Requirements:
- PhD + 4 years pharma experience; or MS + 8 years; or BS in Microbiology/related Biological Sciences + 12 years.
Required Experience/Skills:
- GMP microbiology testing expertise; EM program leadership aligned with EU GMP Annex 1.
- Risk-based EM strategy design; EMPQ, requalification, periodic review; EM data trending/statistics (e.g., MODA).
- Knowledge of aseptic manufacturing, contamination control, quality investigations, audits, and current regulatory/industry guidance.
Preferred Skills:
- Testing in clean room environments; aseptic process validation.
- MODA, SAP, Veeva, LIMS.
Application:
- Apply at https://jobs.merck.com/us/en. Application deadline stated on posting (Job posting end date: 07/6/2026).