Experienced Validation Engineer

( Part-Time, Full-Time, Contract)
Validation of process equipment and systems; preparation of component/system specifications and qualification test protocols; development of standard operating procedures (SOPs) and annotated process control diagrams; on-site testing; data analysis; and preparation of final reports. Knowledge of GMP
and CFR Regulations.

Looking for a full / part time or contract based experienced Validation Engineer. Prefer a background in Quality Assurance or Chemical/Mechanical Engineering with experience in Equipment Installation/Startup. Position requires excellent written and verbal communication skills (technical writing experience preferred). Successful candidate will be involved in Validating process equipment; preparation of system specifications and qualification test protocols; development of standard operating procedures (SOPs), Installation/Operational Qualifications (IOQs), Performance / Qualifications (PQs), and Process validation.; on-site testing; data analysis; and preparation of final reports. Should be familiar with P & I.D.drawings and diagrams. Applicant needs to be computer literate with experience in Microsoft Word and Excel. The successful candidate will be validating the following types of equipment:

• Aseptic Filling / Plugging / Capping Equipment.
• Centrifugal and Mechanical (Positive
  Displacement and Peristaltic) Pumps.
• Clean Rooms / HEPA filters.
  (will be conducting smoke studies)
• Depyrogenation Ovens,Tunnels, and Steam Autoclaves
  (familiarity with Kaye Validation Equipment a plus).
• Human Drug Products [Vitamins, Steroid's, and other Drugs]
• (Familiarity with the FDA's cGMP and ISO 9000 standards a plus).
• HVAC Systems.
• Clean Steam System
• Reverse Osmosis / Deionized Water System
• Clean Dry, Compressed Air System
• Labeling Equipment.
• Mixers.
• Purified Water Systems.
• WFI (Water For Injection) Systems.
• Day to day activities include, but are not limited to the following:
  
  Analyze requirements for Testability & determine Testing method. Prepare test procedures, Validate test procedures in the laboratory facilities and report problems encountered (support investigation of the problems & verify corrections to the problems); Summarize validation progress in debriefings with customer reps and document the results. Applicant last be able to work independently. Please Provide a list of test and measuring equipment you are familiar with.