A leading medical devices manufacturing company in Abu Dhabi is seeking a Microbiologist – QC to join its Quality Control Department. The ideal candidate will be responsible for performing microbiological testing, sterility assurance, environmental monitoring, laboratory documentation, and supporting compliance with international quality standards including ISO 13485, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable regulatory requirements.

This role is essential in ensuring that medical devices are manufactured in a controlled environment and consistently meet microbiological quality, safety, and regulatory standards before release to the market.

Key Responsibilities – Microbiologist

• Prepare microbiological culture media, reagents, biological indicators, and other laboratory materials following approved procedures.
• Perform sterility testing of finished medical devices using validated microbiological methods.
• Conduct bacterial endotoxin testing (BET/LAL Test) to ensure products comply with regulatory specifications.
• Perform bioburden analysis for non-sterile medical devices, components, and raw materials.
• Carry out microbiological environmental monitoring of cleanrooms, including:
  • Air monitoring
  • Surface monitoring
  • Personnel monitoring
  • Water sampling
  • Compressed gas monitoring (where applicable)
• Monitor microbiological quality of purified water and laboratory utilities.
• Perform microbial identification using standard microbiological techniques.
• Maintain laboratory reference cultures and microbial stock organisms.
• Record, review, and maintain accurate documentation for all microbiological testing activities.
• Prepare laboratory reports in accordance with Quality Management System (QMS) requirements.
• Conduct real-time and accelerated stability testing as per approved stability protocols.
• Manage retain samples for each manufacturing batch according to company procedures.
• Ensure proper handling, cleaning, maintenance, calibration, and verification of microbiology laboratory equipment.

• Perform media preparation, growth promotion testing, and media qualification.
• Participate in validation studies including:
  • Sterilization validation
  • Cleaning validation
  • Method validation
  • Process validation support
• Perform microbiological qualification of new raw materials, packaging materials, and suppliers.
• Evaluate microbiological performance of new and existing products whenever required.
• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and contamination incidents.
• Support implementation of Corrective and Preventive Actions (CAPA).
• Ensure laboratory activities comply with GMP, GLP, ISO 13485, and company Standard Operating Procedures (SOPs).
• Participate in internal quality audits, customer audits, and regulatory inspections.
• Review and update microbiology-related SOPs, specifications, and laboratory procedures.
• Support contamination control programs within manufacturing and laboratory areas.

• Maintain laboratory housekeeping and ensure proper disposal of microbiological waste according to biosafety requirements.
• Coordinate with Production, Quality Assurance, Engineering, and Regulatory Affairs departments to resolve microbiological issues.
• Train laboratory personnel on microbiological techniques, aseptic practices, and contamination prevention.
• Perform trend analysis of environmental monitoring and microbiological test results.
• Recommend quarantine or rejection of products that do not meet microbiological acceptance criteria.
• Perform additional duties assigned by the Quality Control Section Head.

Job Qualification

• Bachelor’s Degree in Microbiology, Biological Sciences, Biotechnology, or a related Life Science discipline.
• Master’s Degree in Microbiology is an added advantage.
• Minimum 2 years of experience in a microbiology laboratory within the medical devices, pharmaceutical, biotechnology, healthcare, or sterile manufacturing industry.
• Experience working in controlled cleanroom environments is highly preferred.
• Hands-on experience in sterility testing, environmental monitoring, and bioburden testing is required.

QC MIcrobiologist – Abu Dhabi

• Strong knowledge of microbiological laboratory techniques.
• Excellent understanding of aseptic practices and contamination control.
• Hands-on experience with sterility, endotoxin, and environmental monitoring programs.
• Familiarity with ISO 13485, GMP, GLP, and medical device quality regulations.
• Knowledge of microbiological laboratory investigations and CAPA processes.
• Good analytical, troubleshooting, and root cause analysis skills.
• Excellent documentation and record management abilities.
• Strong computer literacy, including Microsoft Office applications.
• Good communication skills in written and spoken English.
• Ability to prioritize multiple laboratory activities while maintaining high accuracy.

Microbiologist – Skills

Candidates with knowledge of the following standards will be preferred:

• ISO 13485 – Medical Devices Quality Management System
• Good Manufacturing Practices (GMP)
• Good Laboratory Practices (GLP)
• ISO 14971 Risk Management
• Sterility Assurance Principles
• Environmental Monitoring Programs
• Biosafety Guidelines
• Laboratory Data Integrity Requirements
• Validation and Qualification Practices