Commissioning & Qualification Specialist – San German, PR

Help the site complete Commissioning and Qualification activities for Project PCAS such as but not limited to: Area mappings, Blender qualifications, Environmental qualifications in PKG, etc.

Support and lead all aspects of the Commissioning and Qualification (C&Q) program Life Cycle from design through operation and maintenance.
Develop and manage the commissioning and qualification program of the site.
Assure compliance with cGMP, GAMP and ISPE guidelines.
Prepare site validation documentation such as User requirements, design and functional specifications, qualification protocols, master plans, risk assessments, periodic reviews, etc.
Coordinate contractors for multiple projects and assure projects are well documented in the site change control system.
Support with other functions like 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.