08 Mar
Validation Engineer IV
Vacancy expired!
Currently seeking a Sr. Validation Engineer for a large Medical Device company located in San Diego CA.Candidate will provide technical development, creation and executing of all cleaning validations within the Technical Operations department.Responsibilities
- Working directly with another Engineer cleaning and mixing validations
- Draft, review and execute verification / validation protocols, identify validation risks and impacts for all cleaning processes in the Technical Operations department.
- Perform gap assessments in the manufacturing process to ensure all cleaning processes comply with ISO 13485 and FDA standards and complete the remediation requirements.
- Leverages understanding of equipment calibration, maintenance, pFMEAs and facilities to support and maintain validations.
- Interfaces with equipment, measurement systems and processes as required for the optimization and execution of validation activities.
- BS degree; or equivalent in Engineering, Chemistry or related field or equivalent experience
- 10+ years of experience in related field with experience in cleaning validations
- Exposure to validation of in-vitro diagnostic device and medical device manufacturing processes
- Knowledge of federal and other regulations governing medical device assembly and design, e.g. GMP, QSR, ISO and CMDR
Vacancy expired!