Validation Manager

Greater Des Moines area, IA

Job ID: 131980 Industry: Medical Device

Validation Manager

Environment:

Our client is a large manufacturer of Class II IVD devices. Currently doing a large scare validation project of all of their manufacturing equipment and processes. We are looking for a Validation Manager to help work with our client to write up and execute IQ, OQ and PQ protocols and reports.

Principle Duties and Responsibilities:

The ideal candidate will have 7-10+ years of medical device experience (IVD experience is a plus) and have most recently been in a Validation Manager or Lead Validation role. Looking for someone who can help assist and manage progress throughout this validation project. If this equipment or process can’ t be fully validated in accordance to FDA standards, this person will be responsible for reporting why and what actions need to be taken to bring it up to standard (i.e. environmental  controls, timing/temp data logs, posted SOP doc, calibration certifications, etc). Those reports would be used to drive facility and equipment upgrades in the next year or two. 

The instrument components and reagents are manufactured at one of their other facilities and assembled at this plant. This project scope only encompasses the facility where the assembly takes place. The flow diagrams will list the manufacturing process and it’ s critical control points for the six chemistries and instrument assemble. The current MVL consists of, but not limited to the following:
  • 300 Gallon Reactor
  • Centrifuge
  • Distiller
  • Industrial Dryers
  • Bottling Line (both solution and powder)
  • Ampoule filler/seal
  • Lab Instruments (scales, spectrophotometer, PH meter, turbidimeter)
  • TOC Analyzer
  • Refrigerators for chemical storage
  • Printers

 

Required:
  • Medical Device/ IVD Experience
  • Validation Manager (one or two contractors may end up reporting to this person)
  • Protocol Writing – IQ/OQ/PQ    
  • Creation of Project Plans
  • Critical Thinking
  • Ability to drive deliverables

Job Type: Contract

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