Job Information
ThermoFisher Scientific Microbiologist II - 12 Rotating Shift in Joo Koon Circle, Singapore
Work Schedule
Rotational shift days
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Job Description
Join Thermo Fisher Scientific’s 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 facility's 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: Bachelor’s 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.