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.
Responsibilities include development of Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix, validation protocols (IQ/OQ/PQ) and procedures for new and existing computers systems, as well as directly executing validations, evaluation of quality issues and/or deviations reported during validation protocol execution.
Education and/or experience:
• BS in Engineering, preferably Computer, Mechanical, Industrial, Electrical, Chemical, or Biomedical.
• Master Degree is a plus.
• 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.