Technical Specialist Validation Services

Overview

Technical Specialist in Validation Services at Sartorius, executing laboratory validation protocols to deliver high-quality validation testing services in line with internal standards and regulatory requirements.

What you'll do

• Coordinate and execute microbiological and physicochemical studies for filter validation activities (Confidence Projects) based on validation protocols and SOPs, following Good Laboratory Practices (GLP) and considering GMP principles as applicable.
• Complete laboratory data forms, interpret results, submit records for final approval, and document test results in the specified format according to Good Documentation Practices.
• Inform the Manager of deviations related to validation protocols and test execution, and initiate and complete investigations related to protocol deviations or out-of-specification results.
• Prepare SOPs, EOPs, qualification protocols, qualification reports, technical reports, and other related documentation.
• Support routine maintenance of departmental instruments, oversee maintenance and repairs performed by third parties, and support inventory management.
• Ensure the validation laboratory complies with Company Laboratory Quality Assurance and Safety Manuals, and prepare for and participate in customer and ISO audits.
• Ensure proper storage and disposal of hazardous waste, maintain safety records and Material Safety Data Sheets, and coordinate the preparation and maintenance of microbial culture strains, culture media, test solutions and reagents according to SOPs or specific test requirements.
• Conduct other laboratory-related tasks as specified by the Manager.

What you'll need

• Master's degree in Microbiology or Biotechnology, or a postgraduate qualification in a related field.
• 2–5 years of professional experience within the pharmaceutical industry, biopharma, or a contract manufacturer.
• Knowledge of analytical testing procedures, including microbiological tests such as growth promotion testing and media preparation.
• Awareness of calibration and qualification activities.
• Knowledge of sterilizing-grade filter applications within pharma or biopharma.
• Good understanding of GMP and GDP requirements.
• Knowledge or hands-on experience with LIMS, ELN, and Microsoft tools.

Details

• Location: Bangalore.