Validation Engineer (Contract)

Seattle, Washington, United States


SUMMARY:

AGC Biologics is seeking an energetic and enthusiastic individual with a strong background in Validation or Engineering in biotechnology and/ or pharmaceutical manufacturing to join the Validation Team within the Quality Group. This position will primarily contribute to the qualification/validation of facilities, utilities, laboratory equipment, and computer systems and the maintenance of a validated state for existing equipment. Additionally, this position will lead complex validation projects and teams.

PRINCIPAL RESPONSIBILITIES:

  • Generate, review and execute qualification/validation documents for the qualification/validation of facilities, utilities, laboratory equipment, cleaning, and computer systems.
  • Evaluate specifications to determine test scripts and acceptance criteria to demonstrate that the equipment is fit for its intended use.
  • Perform validation impact assessments
  • Investigate, resolve and close deviations and associated CAPAs.
  • Generate and maintain validation templates, procedures, master plans and reports
  • Apply risk analysis methods to validation
  • Lead complex validation projects and teams
  • Train and coach Validation Engineers in validation principles
  • Generate and review Change Controls and SOPs

KNOWLEDGE, SKILLS & ABILITIES:

  • Excellent technical writing skills. In-depth knowledge of pharmaceutical processing. Qualification of facilities, utilities, manufacturing equipment and analytical equipment including automated equipment, validation of sterilization processes and IT-based computerized systems.
  • Proven expertise in planning/organization/execution of validation activities, following up on results and resolving complex problems with cross functional teams.
  • Ability to work hours necessary to support production and /or maintenance activities.

EDUCATION/EXPERIENCE:

  • BS degree in Life Sciences, Engineering, or related discipline required.
  • 2 plus years’ experience in a regulated pharmaceutical/medical technology environment required
  • Previous direct experience with regulatory inspections highly desirable