Job description
Day-to-Day :
A large pharmaceutical employer is seeking a Validation Engineer to join their team in Raritan, NJ.
A large pharmaceutical employer is seeking a Validation Engineer to join their team in Raritan, NJ.
- This Engineer will be aligned to the CAR-T therapy and overall validation and qualification activities.
- Overall objective of this project will be to establish the requalification program in relation to Annex 1.
- This will include reviewing equipment, CPPs, executing Annex 1 templates, and overall risk assessments for those that need requalification and ultimately establishing the process moving forward.
- This resource will be expected to be on site in Raritan, NJ 5 days per week.
Plusses
- Experience with CAR-T
Desired Skills and Experience
- 10+ years Validation & Equipment Qualification Experience
- Experience within Sterile Pharmaceutical Products and Cell Gene Therapy
- Knowledge of Annex 1 and aseptic processing
- Experience with requalification of pharmaceutical manufacturing equipment
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