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Validation Scientist I

Charles River Laboratories
Charleston County, SC
Closing date
Jan 15, 2022

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For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.
Job Summary
We are seeking a Validation Scientist I for our Microbial Solutions site located in Charleston, SC.

Primarily responsible for performing GMP-compliant validation studies related to demonstrating Celsis as an acceptable Alternative Microbiological Method. Performs microbiological testing in support of laboratory functions, such as growth promotion and trial studies. Serves as a resource for customer applications, assist customers via phone and email, and supports and leads customer complaint investigations. Assists with more complex technical queries from customers and may correspond directly with customers via email or teleconference. Writes reports related to validation activities and process these through QA-controlled systems. Assist with daily tasks of maintaining supply materials, laboratory maintenance activities and ordering supplies. Receives customer samples and disposes of microbial cultures according to current SOPs.

The following are the duties and responsibilities related to the Validation Scientist I:
  • Is capable of understanding and applying requirements related to Alternative Microbiological Method Validation
  • Provide technical support for internal and external Celsis customers through bacteriologic analysis utilizing varying instrument platforms and laboratory testing procedures; samples can include raw materials, pharmaceutical drugs, or cell cultures
  • Perform the full scope of bacteriologic analysis including isolation, growth, maintenance of cultures, and discrepancy resolution
  • Independently perform microbiological testing methods including bioburden, sterility, and micro limits testing based on defined customer criteria
  • Collaborate with Technical Services leadership and team members on customer support and special projects; serve as back-up on all lab functions
  • Comply with SOPs, SDS sheets, and laboratory procedures to ensure the integrity of our data
  • Has an ongoing understanding of various regulatory regulations as applicable to products tested in the Celsis laboratory
  • Maintain records compliance by adhering to regulatory guidelines set forth by the company and varying agencies
  • Process, receive, unpack, log, customer samples according to current SOPs
  • Dispose of microbe cultures, chemicals and glass in designated waste containers
  • Perform all other related duties as assigned

Job Qualifications
The following are the minimum requirements related to the Validation Scientist I:
  • Education: Bachelor's Degree in related life sciences discipline
  • Experience: 2-7 years related microbiological experience with Bachelor's Degree, 0-5 years related microbiological experience with Master's Degree
  • Certifications/Licensures: None
  • Must be comfortable working collaboratively or individually
  • High standards for integrity and quality of work performed
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Skills and Abilities:
List key hard and soft skills for the role such as organizational skills, proficient with various softwares, interpersonal skills, etc.

About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
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