- Mechanical Engineering Experience
- FDA Regulations
manufacturing and packaging Equipments, Utilities, and Product storage units validation
protocols using DOSA, CVC, TPM, TQM; Design qualification of pharmaceutical clean rooms
and perform all aspects of cleaning validation; Install and maintain IMA Injectable Powder
Filling and Packing lines and Solid oral dosage process line using RMG/FBP; Analyze, asses,
and optimize validated systems in compliance with cGMP/SOP’s and FDA regulations; Perform
Installation and Validation co-ordination for Sterile and Non-Sterile Process Equipment using
Snowbell Sterilization Tunnel (ST 600).
Must have a Bachelor’s Degree in Manufacturing Engineering or Mechanical Engineering plus 3
years experience in job offered, Mechanical Engineer, or Executive Mechanical Engineering. As
alternative to Bachelor’s, 1 year college plus 5 years experience is acceptable. Require skills and
working knowledge of cGMP/SOP’s, IMA, Snowbell Sterilization Tunnel (ST 600), RMG/FBP,
DOSA, CVC, TPM, TQM.
Job location: Newtown, PA. Submit résumé referencing job code SRS001 to HR, KVK-Tech,
Inc., 110 Terry Drive, Suite 200, Newtown, PA 18940.