Microbiologist II 12 Rotating Shift

Work Schedule

Environmental Conditions

Job Description

Job Description

Join Thermo Fisher Scientifics Quality Control team as a Microbiologist II. You will ensure cGMP and regulatory compliance while delivering analytical solutions through expertise in microbiology method qualification/validation and timely project completion. Responsibilities include overseeing lab activities leading investigations and promoting quality culture and compliance across the site.

Responsibilities:

• Perform quality control microbiological testing of raw materials incoming goods intermediates and/or finished products under cGMP conditions for QC release or as part of stability studies.

• Perform monitoring for facilitys utilities systems
• Perform method transfer/verification/validation.
• Manage the Environmental Monitoring Program of site.
• Perform Risk Assessment related to Environmental Monitoring.
• Manage daily lab operations in compliance with GMP and company standards.
• Update processes in response to new pharmacopoeia/regulatory changes.
• Lead lab investigations/deviations and ensure timely closure as per Quality System.
• Review laboratory test data for accuracy and compliance.
• Troubleshoot methods and equipment issues.
• Manage laboratory consumable inventory.
• Support equipment qualification
• Support aseptic process simulations
• Train and maintain training records for team members.
• Stay updated on international regulations (GMP GLP ICH FDA EP and pharmacopoeias).
• SME during audits/inspections.
• Support internal audits inspections and continuous improvement (PPI).
• Promote Quality Culture and 4i values.
• Adhere to HSE GMP and 5S standards.
• Carry out any other tasks required by reporting Manager
• Support shift work as needed.

Requirements

Education:Bachelors degree in Microbiologist Biochemistry Biology Molecular Biology or related scientific field

Experience:

• Minimum 5 years in pharmaceutical/biotech Quality Control.
• Knowledge of FDA EMA HSA PIC/S and ICH regulations.
• Strong cGMP knowledge and QC Microbiology techniques.
• Experience with method transfer and validation.
• Familiar with Risk Management and Environmental Monitoring Program
• Excellent communication skills in English.
• Ability to work both independently and collaboratively in a team environment and under regulatory scrutiny.
• Audit and inspection readiness experience.