Technical Specialist Validation Services

Sartorius; Bengaluru; Presencial; INR 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

Sartorius in Bengaluru is seeking a Technical Specialist Validation Services to lead microbiological and physicochemical validation testing, ensuring compliance with GLP and GMP while supporting customer satisfaction and quality.

You will execute laboratory protocols, prepare documentation, assist audits, and collaborate with cross-functional teams in a global pharma environment. Master’s in Microbiology or Biotechnology and 2–5 years’ experience required.

Formación

• Master's degree in Microbiology or Biotechnology (or related field)
• 2–5 years of professional experience in pharmaceutical/biopharma or contract manufacturing
• Knowledge of analytical testing procedures including microbiology tests and sterilization processes
• Familiarity with GMP and GDP requirements
• Experience with LIMS, ELN, and common Microsoft tools

Responsabilidades

• Coordinate and execute microbiological and physicochemical studies for validation activities following GLP and GMP principles
• Prepare SOPs, qualification protocols/reports, and other technical documents
• Maintain/instrument upkeep and oversee third-party maintenance, inventory management
• Document test results and ensure proper storage and disposal per SOPs
• Assist in audits and ensure compliance with QA and Safety Manuals
• Inform management of deviations and assist in investigations of out-of-spec results

Conocimientos

Microbiology

Biotechnology

Analytical testing

GMP knowledge

Educación

Master's degree in Microbiology or Biotechnology

Herramientas

LIMS

ELN

MS Office

Descripción del empleo

Introduction

Join our Validation Services team as a Technical Specialist Validation Services and play a key role in delivering high-quality validation testing services. By executing laboratory protocols in line with internal standards and regulatory requirements, you will contribute to customer satisfaction and operational excellence, supporting better health for more people. The position is based in Bangalore.

Your Responsibilities

• 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, coordinate the preparation and maintenance of microbial culture strains, culture media, test solutions and reagents according to SOPs or specific test requirements, and conduct other laboratory-related tasks as specified by the Manager

What will convince us

• 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; and 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

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution.