For nearly 75 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

Full-time Validation scientist is required to operate under the Technical Services Department. Validation scientist is responsible for organisation, execution and documentation of all activities associated with the Celsis complete package within the Technical Services Celsis laboratory.

JOB QUALIFICATIONS

Education: Degree in Microbiology, Biology or a related discipline.

EXPERIENCE:

Demonstrable track record of established experience in cGMP pharmaceutical microbiology environment is essential. In particular the use of Sterility and Bioburden testing and validation. Experience in the use of Celsis technology is preferred, however full training will be provided.

• Determine methods and procedures on new assignments (assist the Lab Management in creating customer protocols for Celsis Complete packages).
• Assist Management in projects such as Implementation or new processes/ Product Validation/ Process validation.
• Perform laboratory activities necessary to isolate, grow and maintain cultures of bacteria.
• Ensuring they are up to date on all training new Celsis technology and regulatory requirements for processes associated with Celsis complete within the Technical Services Laboratory.
• To be the designated person/ SME who will pass the training on to the remaining lab members.
• Perform training with new analysts (theory and practical) on all different Celsis kit types and assist with the documentation of all training records in accordance with the site GDP.
• Collaborate with inventory check of laboratory consumables and assist with general housekeeping of the laboratory, performing equipment maintenance and scheduling instrument calibrations or qualifications.
• Ensure adherence to pertinent regulatory requirements (cGMP, FDA, ISO) and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
• Assist management with development and revision of departmental standard operating procedures and qualification documents.
• Assist management with reporting of any quality issues through LIRs, OOS, Dev and CAPAs.
• Assist management in managing TAT for projects within the Celsis and Endosafe lab and ensure that progression of all projects is communicated to management during the weekly team meetings.
• Perform all other related duties as assigned.