JobMesh

Director, Validation

Civica Rx · Petersburg, Virginia, US

Job Description This position will build and lead the Validation function at the Petersburg, VA manufacturing site.

Job description

Job Description This position will build and lead the Validation function at the Petersburg, VA manufacturing site. The Director of Validation is responsible for developing and implementing the validation strategy for the site and leading the Commissioning, Qualification and Validation activities to ensure facilities, utilities, and equipment are qualified based on intended use. In addition, they will develop the cleaning validation strategy. We are seeking an exceptional leader who thrives in a fast-paced environment to oversee the Validation function. 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...