This position is no longer open for applications

Manage all aspects of the Validation Life Cycle from design through operation and maintenance to retirement. Responsible for the preparation of laboratory validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews.

• Work closely with validation contractors and quality control to generate and execute equipment qualification documents.
• Coordinate and supervise validation testing performed by vendors and validation contractors.
• Represent validation in multi-disciplinary teams focused on commissioning, validation, and computerized system validation.
• Support the Periodic Review’s and revalidation program.
• Ensure site alignment with corporate standards and cGxP guidelines.

60

Author and revise validation documents within the electronic documentation management system.

10

Work independently and/or with subject matter experts (SME) and 3^rd party validation contractors to implement and/optimize key validation and quality initiatives.

10

Work with QA and subject matter experts to initiate and implement corrective and preventive actions.

10

Identify areas for continuous improvement - Yellow Belts, Process Improvements, 5S, Visual Management. 

5

Ensure compliance for both self and direct reports in site procedures and quality activities. Provides training for validation contractors.

5