Validation Engineer (Contract)
Seattle, Washington, United States
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.
- 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.
- 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