Computer System Validation

This position is responsible for the qualification and validation of computer and automation systems. Plans, coordinates, and participates in a compliant validation process for computer and/or automation systems which require formal validation documentation under appropriate regulatory requirements and company standard procedures.
Education and/or experience: BS in Engineering, preferably Computer, Mechanical, Industrial, Electrical, Chemical, or Biomedical. Master Degree is a plus. PE License strongly desired. Lean/Six Sigma Green or Black Belt Certification is a plus. Experience in validations such as: manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, packaging, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required. Minimum of four (4) years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least three (3) years in a validation engineering position.