Job Description

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.)

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 3+ 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.