Essential Duties and Responsibilities

· Develop the validation strategy for the site and maintain the Validation Master Plan.

· As a member of the site leadership team contributed to the strategic initiatives and operational plans for the site.

· Implement validation policies and related procedures based on regulations and industry standards.

· Oversee the authoring and review of SOPs, protocols, reports and Validation Master Plans for cGMP equipment, utilities, cleaning, analytical methods and instruments.

· Implement and manage cleaning validation programs. Plan validation efforts using a risk-based approach.

· Provide oversight and direction to Aseptic Processing Simulation (APS) and Air Visualization Studies.

· Lead Change Control activities and support Tech Transfers to ensure validation activities are identified to support new and existing products.

· Mentor, coach, train and develop validation staff.

· Provi...