Validation Services Laboratory Specialist

5 days ago

Bengaluru, Karnataka, India Sartorius Full time ₹ 12,00,000 - ₹ 24,00,000 per year

We are seeking a highly skilled Validation Services Laboratory Specialist to join our esteemed Confidence Validation Services Team at our Bangalore laboratory. In this onsite role, you will plan, execute, and document customer-specific process validation studies focused on the process application of sterilizing-grade filters and other Sartorius products (as may apply). Your expertise will be crucial in performing validation activities with regard to microbiological and physicochemical studies of Sartorius products, including sterilizing grade filters. You will ensure these activities align with intended usage, customer process conditions, and any future requirements. This onsite position is integral to our Validation Laboratory function, where we provide exceptional support to our Biopharma and Pharma clients. If you are passionate about delivering excellence and contributing to the success of our customers, we invite you to apply for this exciting opportunity.

The Validation Services Laboratory Specialist will execute microbiological and physicochemical testing on sterilizing‑grade filters and other Sartorius products in accordance with approved validation protocols; analyze and interpret results against defined acceptance criteria, ensure accurate and complete laboratory data, review records for compliance, and submit finalized documentation for approval.

Main Responsibilities & Tasks:

  • Provide qualification / validation quality / compliance support compliant with laboratory safety procedures and requirements of Sartorius Stedim
  • Perform viability, bacterial challenge, product specific integrity and chemical compatibility tests according to Sartorius standard operating procedures and approved validation protocols
  • Perform in-coming material testing
  • Prepare strains, culture media, test solutions and reagents necessary for the performance of all laboratory tests
  • Handle biological indicators, cultures, chemicals and test solutions according to government regulations and company standard operating procedures
  • Complete laboratory data form, interpret results and review
  • Inform laboratory manager of any deviations related to validation protocol execution
  • Initiate and complete any investigations related to deviation of validation protocols or out of specification results
  • Perform necessary cleaning and sanitizing of the laboratory and equipment after testing
  • Check daily monitoring data of laboratory environment and temperature controlled equipment
  • Perform inventory control of consumables and standard reagents to ensure the safety stock
  • Perform qualification, calibration and maintenance of relevant equipment or devices
  • Review validation protocols and validation reports
  • Assist in maintenance of standard operating procedures, including writing and revising

Qualification & Skills:

  • Academic or technical M.Sc Microbiology / M.Pharma
  • 1-3 years of work experience in Biopharma/Biotech/Pharma/Filtration
  • Hands on experience with the Digital applications like LIMS /ELN is a plus.
  • Good understanding of GMP requirements
  • Familiar with microbiological analysis testing and operating related equipment
  • Self-sufficient, target oriented, well organized and self-motivated work style
  • Good communication and problem-solving skills
  • Experienced with project management and teamwork (ideally in a global environment)
  • Team and customer service orientated attitude
  • Proven software skills, e.g. Microsoft Office
  • Fluent in English

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