The role is responsible to support and lead all aspect of the Commissioning and Qualification (C&Q) program Life Cycle from design through operation and maintenance. The role will develop and manage the commissioning and qualification program of the site. The resource will assure the compliance with cGMP, GAMP and ISPE guidelines. The role is responsible to prepare site validation documentation such as User requirements, design and functional specifications, qualification protocols, master plans, risk assessments, periodic reviews, among others. The resource will coordinate the work of contractors for multiple projects and will assure the projects are well documented in the site change control system. The resource could support for a limited time other functions such as project management and technical evaluations for the site.
A bachelor’s degree in Science such as Pharmacy, Engineering, Biotechnology, Chemistry, Physics or Biology. Minimum of 5 years of experience in a highly-regulated industry like Pharmaceuticals and/or Medical Device. Knowledge in cGMP, GAMP, ISPE and computerized system life cycle guidelines. Knowledge on site utilities (HVAC, Compressed air, Purified water, etc). and facility is required.
The position will help the site in completing Commissioning and Qualification activities for Project PCAS such as but not limited to: Area mappings, Blender qualifications, Environmental qualifications in PKG, etc.