Laboratory Technician - Sterile Product Testing (SPT)

The Laboratory Technician in Sterile Product Testing (SPT) is responsible for performing microbiological testing of sterile pharmaceutical products to ensure compliance with regulatory standards and client specifications. Key responsibilities include: - Conducting sterility testing, bioburden analysis, and endotoxin testing on pharmaceutical samples using aseptic techniques. - Preparing and sterilizing media, reagents, and equipment according to standard operating procedures (SOPs). - Performing environmental monitoring of cleanroom facilities, including viable and non-viable particle counts, and surface sampling. - Documenting test results accurately in laboratory information management systems (LIMS) and maintaining detailed records for audit trails. - Interpreting test data, identifying deviations, and reporting out-of-specification results to supervisors. - Maintaining aseptic conditions in cleanroom environments, including gowning, cleaning, and disinfection protocols. - Calibrating and maintaining laboratory instruments such as autoclaves, incubators, and biological safety cabinets. - Supporting method validation and verification studies for new testing procedures. - Collaborating with quality assurance teams to investigate and resolve non-conformances. - Ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and regulatory guidelines (e.g., USP, EP, FDA). - Participating in internal and external audits by preparing documentation and demonstrating procedures. - Managing inventory of laboratory supplies and reagents to ensure uninterrupted testing operations. - Training junior staff on aseptic techniques and laboratory safety protocols. - Adhering to all safety policies, including handling of hazardous materials and waste disposal.

Qualifications and requirements: - Bachelor’s degree in Microbiology, Biology, or a related life science field. - Minimum 1-2 years of experience in a pharmaceutical or biotechnology laboratory, specifically in sterile product testing. - Strong knowledge of aseptic techniques and cleanroom operations. - Experience with sterility testing, bioburden analysis, and endotoxin testing (e.g., LAL assay). - Familiarity with cGMP, GLP, and regulatory standards (USP, EP, FDA). - Proficiency in using LIMS and Microsoft Office Suite. - Excellent attention to detail and documentation skills. - Ability to work in a team-oriented environment and communicate effectively. - Certification in aseptic processing (e.g., from PDA or equivalent) is preferred. - Flexibility to work shifts, including weekends and holidays, as required.

Eurofins Scientific is an international life sciences company providing analytical testing services to ensure safety, authenticity, and accurate labeling of products across industries.