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Validation Engineer

Brickred

Validation Engineer

Seattle, WA
Full Time
Paid
  • Responsibilities

    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