Validation Services Laboratory Specialist
6 days ago
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 StedimPerform viability, bacterial challenge, product specific integrity and chemical compatibility tests according to Sartorius standard operating procedures and approved validation protocolsPerform in-coming material testingPrepare strains, culture media, test solutions and reagents necessary for the performance of all laboratory testsHandle biological indicators, cultures, chemicals and test solutions according to government regulations and company standard operating proceduresComplete laboratory data form, interpret results and reviewInform laboratory manager of any deviations related to validation protocol executionInitiate and complete any investigations related to deviation of validation protocols or out of specification resultsPerform necessary cleaning and sanitizing of the laboratory and equipment after testingCheck daily monitoring data of laboratory environment and temperature controlled equipmentPerform inventory control of consumables and standard reagents to ensure the safety stockPerform qualification, calibration and maintenance of relevant equipment or devicesReview validation protocols and validation reportsAssist in maintenance of standard operating procedures, including writing and revisingQualification & Skills:Academic or technical M.Sc Microbiology / M.Pharma1-3 years of work experience in Biopharma/Biotech/Pharma/FiltrationHands on experience with the Digital applications like LIMS /ELN is a plus.Good understanding of GMP requirementsFamiliar with microbiological analysis testing and operating related equipmentSelf-sufficient, target oriented, well organized and self-motivated work styleGood communication and problem-solving skillsExperienced with project management and teamwork (ideally in a global environment)Team and customer service orientated attitudeProven software skills, e.g. Microsoft OfficeFluent in EnglishAbout 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. We are looking forward to receiving your application.
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Validation Services Laboratory Specialist
6 days ago
Bangalore, Karnataka, India Sartorius Full timeWe 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...
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