Ingeniero Sr. Validaciones de Esterilización
Required Knowledge, Skills, and Experience: Commitment to product quality, the Centerpiece quality system, and all applicable regulations (Federal, Local, and State). Bachelor’s degree in engineering, or related scientific discipline (Electrical, or Chemical Engineering degree preferred) and a minimum of 5 years of progressively responsible experience in a regulated industry such as medical device or pharmaceutical. Thorough and detailed experience with FDA Quality System Regulations (21 CFR 820), ISO 13485 and GHTF process validation guide. Extensive experience in equipment validation and commissioning is mandatory. Experience working in a process environment with in-depth, hands-on involvement. Ability to successfully manage multiple projects simultaneously. Proven technical experience with demonstrated success in working in a team environment to successfully achieve corporate goals related to new facility and equipment qualification and sterilization validation. Experience with the following critical utility/mechanical systems: HVAC and controlled environments.
Hace 8 horas en Tijuana
