Objective of the Position

Maintain efficient operation as well as perform environmental monitoring, bacterial endotoxin testing laboratory (LAL test), Silver Content testing for medical devices and do the sterilization releases, ensuring compliance with applicable regulatory standards (FDA 21 CFR Part 820, ISO 13485, USP <85>), maintain reliability of analytical results, and proper management of human and material/component resources.

Responsibilities

• Responsible to coordinate all environmental control activities for the facility, including certifications, and the periodic review of environmental monitoring results, as well as any tasks related environmental impact, change control and biological tests.
• Responsible to perform and maintenance the Biocontamination assessments for the product families.
• Ensure compliance with Standard Operating Procedures (SOPs).
• Maintain required environmental and control conditions.
• Manage inventory of reagents, consumables, and equipment.
• Schedule and coordinate test execution.
• Supervise, train, and evaluate laboratory technical staff.
• Promote continuous training and a culture of compliance.
• Review and approve test records and reports.
• Investigate deviations or out-of-specification (OOS) results.
• Implement corrective and preventive actions (CAPA).
• Maintain technical communication with corporate and external labs. Participate in internal, corporate, and regulatory audits.
• Participate in method validation, improvement, and process optimization.
• Ensure compliance with ISO 13485, 21 CFR Part 820, and USP <85>.
• Prepare and review procedures and technical reports.
• Review and approve sterilization results prior to release.
• Execute environmental monitoring sampling (viable and non-viable particles, surface monitoring, air and water sampling) according to established procedures.
• Perform endotoxin testing on finished products, subassemblies and raw materials using validated methods (LAL gel-clot, turbidimetric or chromogenic).
• Prepare media, reagents and test materials in accordance with laboratory work instructions.
• Record all test results clearly and accurately in laboratory notebooks, forms and/or electronic systems.
• Ensure traceability of samples and materials used during the testing process.
• Conduct equipment calibration and routine maintenance according to scheduled intervals.
• Assist with method validation studies and trend analysis of environmental and endotoxin results.
• Support investigations related to deviations, out-of-specification (OOS) results or non-conformances.
• Comply with Good Laboratory Practices (GLP) and all applicable procedures within the Quality Management System (FDA 820 / ISO-13485).
• Participate in internal and external audits by providing records and technical information when required.

Requirements

• Bachelor’s degree in laboratory technology, Microbiology, Biotechnology, Chemistry or related field.
• Advanced English level.
• Previous experience in microbiological testing, environmental monitoring or endotoxin testing (preferably within the medical device industry).
• Knowledge of regulatory standards: ISO 13485 and FDA 21 CFR Part 820.
• Ability to follow standard operating procedures and interpret technical documents.
• Advanced knowledge of MS Office tools (Excel, Word and lab software).