Insight Global
Process Validation Engineer
Insight Global, Rocky Mount, North Carolina, United States, 27801
Must Haves:Bachelor's Degree in Engineering, Life Sciences or related field2+ years of process validation experienceAny experience with sterilize productsExperience in pharmaceutical manufacturing within a cGMP environmentExperience authoring technical documentation within a cGMP context
Pluses:Experience with responding to regulatory questions with multiple agencies (e.g. FDA, EMA)Experience doing a tech transferCleaning Validation experienceExperience with sterile injectables
Day to Day:Insight Global is seeking a Process Validation Engineer in Rocky Mount, NC. You will support a diverse variety of qualification activities for manufacturing processes within a biopharmaceutical manufacturing facility. This role has a heavy focus on process validation and sterilization. You will directly be supporting the manufacturing process validation team for small molecule sterile injectable drug products as they ramp up an new production building.
Pluses:Experience with responding to regulatory questions with multiple agencies (e.g. FDA, EMA)Experience doing a tech transferCleaning Validation experienceExperience with sterile injectables
Day to Day:Insight Global is seeking a Process Validation Engineer in Rocky Mount, NC. You will support a diverse variety of qualification activities for manufacturing processes within a biopharmaceutical manufacturing facility. This role has a heavy focus on process validation and sterilization. You will directly be supporting the manufacturing process validation team for small molecule sterile injectable drug products as they ramp up an new production building.