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Validation Services Laboratory Specialist

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Job Location drjobs

Bengaluru - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

We are seeking a highly skilled Validation Services Laboratory Specialist to join our esteemed Confidence Validation Services Team at our Bangalore laboratory. In this pivotal role you will be responsible for conducting process validation on behalf of our valued customers. Your expertise will be crucial in performing validation activities related 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 be responsible for performing microbiological and physiochemical tests according to written validation protocols. The position holder will interpret results complete and review laboratory data and submit records for final 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 incoming 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

  • 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 degree in sciences / engineering or similar

  • 13 years of work experience in Biopharma/Biotech/Pharma/Filtration

  • Experience in the Digital applications like LIMS /ELN is a plus

  • Good understanding of GMP requirements

  • Familiar with microbiological analysis testing and operating related equipment

  • Selfsufficient target oriented well organized and selfmotivated work style

  • Good communication and problemsolving 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

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 realworld 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. We are looking forward to receiving your application.
www.sartorius/careers


Required Experience:

Unclear Seniority

Employment Type

Full-Time

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