Job Description
Job Summary:
- The Lab Technician is responsible for supporting laboratory and cleanroom-based testing activities to ensure product quality, contamination control, and regulatory compliance.
- This entry-level role involves performing routine environmental monitoring, microbiological and chemical testing, and assisting with quality system processes in a controlled laboratory environment.
- The role requires strict adherence to cleanroom behaviours, good documentation practices, and quality standards to support manufacturing and quality control operations.
Duties and Responsibilities:
Cleanroom & Environmental Monitoring:
- Follow and maintain qualification in ISO 7 and ISO 8 cleanroom gowning procedures to ensure compliance with contamination control standards.
- Perform routine Environmental Monitoring (EM), including viable and non-viable sampling in classified cleanroom areas.
- Support monitoring of cleanroom conditions and report any deviations from expected standards.
Laboratory Testing:
- Conduct microbiological and chemical testing including:
- Bioburden.
- Bacterial endotoxin (LAL).
- Total Organic Carbon (TOC).
- Conductivity.
- Perform particulate matter testing in accordance with USP <788> requirements.
- Assist with sample preparation, handling, and documentation.
Microbiology Activities:
- Support incubation, enumeration, and recording of microbiological results.
- Perform growth promotion testing and sterility verification of media.
- Ensure accurate data recording and reporting in line with laboratory procedures.
Quality & Compliance:
- Follow standard operating procedures (SOPs) and work instructions at all times.
- Support investigations including deviations, non-conformances, and out-of-specification (OOS) results.
- Assist in the implementation of corrective and preventive actions (CAPAs).
- Maintain accurate and compliant documentation to support audits and inspections.
Data & Reporting:
- Assist in trending of environmental and laboratory data.
- Support preparation of routine reports (e.g., monthly or quarterly summaries).
- Escalate abnormal trends or results to senior staff.
Continuous Improvement & Teamwork:
- Participate in daily team meetings (e.g., SQDIP) and contribute to problem-solving activities.
- Collaborate with cross-functional teams including Quality, Manufacturing, and Facilities.
- Support updates to work instructions and laboratory documentation where required.
Qualifications & Experience:
Essential:
- Degree or equivalent in Microbiology, Biology, or a related scientific discipline.
- Basic understanding of laboratory techniques and aseptic practices.
- Strong attention to detail and good organisational skills.
- Ability to follow procedures and work in a regulated environment.
Desirable:
- Exposure to cleanroom environments (ISO 7 / ISO 8).
- Basic knowledge of environmental monitoring or microbiological testing.
- Understanding of GMP, quality systems, or regulated industries.
Key Skills & Behaviours:
- High level of accuracy and attention to detail.
- Strong documentation and data integrity mindset.
- Good communication and teamwork skills.
- Willingness to learn and develop technical skills.
- Proactive and quality-focused approach.
Working Conditions:
- Work in controlled laboratory and cleanroom environments.
- Requirement to wear appropriate PPE and cleanroom gowning.
- May involve standing for extended periods and handling laboratory equipment.
Career Development:
This role provides foundational experience in contamination control, microbiology, and quality systems, with progression opportunities into:
- Senior Lab Technician.
- Microbiologist.
- Quality Control / Quality Assurance roles.
- Contamination Control & Sterility Assurance specialist roles.