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.