Validation Services Laboratory Specialist

Year    Bangalore, Karnataka, India

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 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
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. We are looking forward to receiving your application.

Skills Required

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Job Detail

  • Job Id
    JD4691783
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Bangalore, Karnataka, India
  • Education
    Not mentioned
  • Experience
    Year