Lead Microbiology Scientist, GMP Environmental Testing

Merck; Rahway (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Merck & Co., Rahway, NJ, is seeking a Senior Scientist to join the Analytical Research and Development Microbiology team. You will support GMP microbiology labs, including finished products testing, utilities monitoring, and environmental monitoring within a fast-paced, cross-functional setting.

You will build a robust, risk-based contamination control strategy and lead EM lifecycle activities with emphasis on data integrity and ALCOA+ principles.

Qualifications

• Strong microbiology lab experience in GMP environments.
• Experience with EM/Utilities monitoring and product testing.
• Experience leading investigations and CAPA in QA contexts.
• Knowledge of regulatory guidelines and USP where applicable.

Responsibilities

• Schedule and lead environmental monitoring and microbiological testing in GMP lab.
• Provide QC microbiology expertise for sterile and non-sterile operations.
• Manage EM program including sampling, data review and trend reports.
• Lead investigations, root-cause analysis and CAPA closure.
• Collaborate with Quality, Engineering, validation and Operations.

Skills

Environmental Monitoring

GMP Compliance

Microbiology

Problem Solving

Interpersonal Skills

Education

Bachelor's degree in Microbiology / related field

7+ years pharma industry with BS

MS with 4+ years pharma

PhD with 1+ year pharma

Tools

MODA

SAP

Veeva

Job description

Merck & Co., Rahway, NJ, is seeking a Senior Scientist to join the Analytical Research and Development Microbiology team. You will support GMP microbiology labs, including finished products testing, utilities monitoring, and environmental monitoring within a fast-paced, cross-functional setting.

You will build a robust, risk-based contamination control strategy and lead EM lifecycle activities with emphasis on data integrity and ALCOA+ principles.