Validation Engineer (Packaging)

EQVAL Group, Inc. is a company that provides services to the manufacturing industry ( Medical Devices, Pharmaceuticals, Biotechnologies, others ). We work with an extraordinary group of professionals ( employees and contractors ) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service. The Validation Engineer (Packaging) must be a subject matter expert (SME) in packaging process. The primary responsibility will be provide support with validation activities (equipment, process, etc.) and change controls. Minimum Requirements: Experience on sealing process for medical devices (rigid trays/Tyvek lids, pouches), transportation / shipping validation, shelf life / aging studies and Test Method validation. Knowledge of ISO 11607 part 1 and 2 for sterile barrier packaging. Thorough understanding of packaging and transit (transport) testing and performance test methods (conditioning, compression testing, drop testing, vibration testing, bubble leak test, among others). Knowledge in shelf-life validation (aging studies), sterile barrier sealing process validation and packaging validation. Knowledge and working experience in package and sealing integrity tests as well as package seal strength tests such as: seal strength (peel) test, burst test, creep test, bubble leak test, peeling down and dye penetration, among others. Strong project management skills. Minimum of 3 years of experience in the medical device and/or pharmaceutical manufacturing environment. Excellent communicator (spoken, written) in both, English and Spanish. Only local Puerto Rico candidates will be considered . Powered by JazzHR