Technical Specialist Validation Services
Core
Execute laboratory protocols for microbiological and physicochemical studies to validate sterilizing-grade filters in compliance with GMP/GLP.
Role type
Technical Specialist Validation Services
Builds
Validation reports, qualification protocols, and technical documentation for filter validation activities.
Domain
Pharmaceutical/Biopharma manufacturing validation
Required skills
Microbiology, Biotechnology, Analytical testing procedures, GMP, GDP, LIMS, ELN, Sterilizing-grade filter applications
Preferred skills
None stated
Technologies
LIMS, ELN, Microsoft tools
Responsibilities
Coordinate and execute microbiological and physicochemical studies for filter validation; Complete laboratory data forms and document test results; Investigate protocol deviations and out-of-specification results; Prepare SOPs, EOPs, and qualification reports; Support routine maintenance of departmental instruments; Ensure laboratory compliance with quality and safety manuals.
Seniority
Mid-level (2-5 years experience)