Bachelor Degree Required
The Process Validation Engineer (PVE) tests systems and processes as the owner of the process validation program to ensure the highest quality products are manufactured. S/he investigates process deviations, investigates assignable root causes for equipment, system or process failures and establishes appropriate corrective and preventive actions. The PVE ensures processes are performed and documented accurately, timely and in compliance with SOPs, cGMPs and FDA requirements in an ISO 13485 environment.
Ability to understand the development and execution of qualification protocols (IQ/OQ/PQ concepts) and other validation lifecycle documents.-includes software validation
Strong understanding of cGMPs, FDA, OSHA, and other local, state and federal regulatory requirements associated with medical device/orthopedic implant manufacturing facilities and associated equipment
Excellent technical writing and organizational skills
Thorough understanding of basic statistical concepts