Microbiologist

Function as Approved Microbiologist for the manufacturing site.

· Lead establishment and qualification of the Microbiology Laboratory including layout review, equipment selection, workflow design and contamination control strategy.

· Develop microbiology laboratory systems in accordance with GMP and regulatory requirements.

· Prepare and implement laboratory SOPs, specifications, qualification protocols and quality systems.

· Lead IQ, OQ and PQ activities for microbiology laboratory equipment.

· Establish Environmental Monitoring (EM) programs for classified manufacturing areas.

· Design microbial monitoring strategies for cleanrooms, personnel and utilities.

· Develop and qualify media preparation support systems.

· Lead microbiological method validation, verification and method transfer activities.

· Establish Water Monitoring Program including PW, potable water and associated utilities.

· Conduct microbial investigations including environmental excursions, OOS, OOT and contamination events.

· Ensure compliance with Data Integrity, GDP and laboratory quality systems.

· Support regulatory inspections, customer audits and qualification of the microbiology facility.

· Thorough understanding of EU GMP, WHO GMP, PIC/S guidance and global contamination control requirements.

· Ability to represent microbiology function during regulatory inspections and customer audits.

· Experience handling inquiries related to Environmental Monitoring, Water Systems, Sterility Assurance and Contamination Control Strategy.

· Build, train and mentor the microbiology team.