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Sartorius

Bioprocess and laboratory solutions provider

Technical Specialist Validation Services

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBengaluru, Karnataka, IndiaNo salary listedIn-person

About the Job

Requirements

  • A Master's degree in Microbiology or Biotechnology, or a postgraduate qualification in a related field.
  • Two to five 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.
  • A good understanding of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) requirements.
  • Knowledge or hands-on experience with Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and Microsoft tools.

Responsibilities

  • Coordinate and execute microbiological and physicochemical studies for filter validation activities (Confidence Projects) based on validation protocols and standard operating procedures (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.

About the Company

Sartorius

Bioprocess and laboratory solutions provider

Sartorius provides laboratory and bioprocessing equipment and services for biopharmaceutical development and manufacturing. Its products cover end-to-end needs such as bioreactors, single-use technologies, filtration and purification tools, analytics, and lab instruments, enabling researchers to grow, purify, and test biologics. The company differentiates itself with a long history, a broad, integrated portfolio, global support, and strategic acquisitions that expand its services under one trusted partner. Its goal is to help biopharmaceutical companies develop and produce biotech drugs and vaccines reliably at scale.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Göttingen, Germany
Founded
1870

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