Lead and manage the Environmental Monitoring (EM) program for sterile injectable and peptide manufacturing areas (Grade A, B, C, D cleanrooms) including Isolator based lines.
Individual should have thorough knowledge of microbiology as well.
Design, review, and execute EM strategies including:
Viable and non-viable particle monitoring
Air, surface, personnel monitoring
Compressed gas and utility monitoring
Viable settle plate and active air sampling programs
Ensure compliance with regulatory guidelines including EU GMP Annex 1, USFDA aseptic guidance, WHO GMP, and internal CCS (Contamination Control Strategy).
Develop, review, and approve EM SOPs, protocols, and reports.
Lead microbial trending, data evaluation, and periodic review of environmental monitoring results.
Investigate EM excursions, contamination events, and atypical results; perform root cause analysis and implement CAPA.
Involve in change control review and approval, Deviation, Investigation and root cause investigation.
Involve in SOP Review and its implementation and Training.
Coordinate with QA, Production, Engineering, Validation, and QC teams for contamination control and sterile manufacturing assurance.
Ensure qualification and routine monitoring of cleanrooms, LAFs, biosafety cabinets, isolators, and HVAC systems from microbiological perspective.
Oversee microbiological sampling activities during routine production, media fills, and validation batches.
Ensure proper operation, calibration, and maintenance of EM instruments (active air samplers, particle counters, contact plates, etc.).
Maintain aseptic practices and hygiene compliance within controlled manufacturing environments.
Support media fill simulations and aseptic process simulations (APS) with microbiological oversight.
Ensure data integrity compliance (ALCOA+) in EM data recording and reporting systems (LIMS and manual records).
Participate in regulatory inspections and client audits by presenting EM strategy, data, and investigations.
Drive continuous improvement in contamination control practices and EM program effectiveness.
Provide training to microbiology and production personnel on aseptic behavior and contamination prevention practices.
