Validation Engineer IV in San Diego, CA at Volt

Date Posted: 3/23/2021

Job Snapshot

Job Description

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.

Qualifications

  • 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

Volt is an equal opportunity employer