Demonstrate ability to lead technical projects from concept through implementation together with Process Engineering team
Assist with execution of qualification protocols for IQ, OQ
Perform activities like IGI (incoming goods inspection), FAT/SAT and Installation verification for new equipment's and also for existing modified equipment's
Manage equipment construction activities associated with implementation of engineering Projects
Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements
Work with Engineering consultant firms, together with process engineers on equipment reviews and testing
Review P&IDs, standard detail drawings, URS, HAZOP study report
Review 3D model and 2D layouts, general arrangement and isometric drawings for construction & installation
Review detailed specification datasheets for equipment, valves, instruments, piping
Involve Factory Acceptance Testing (FAT) of all process equipment's
Involve in Design Qualification and Commissioning of new/Modified equipment's
Knowledge in change control management and Deviation investigation & closure
Coordinates with multi-disciplinary team for improvements or implementing changes
Requirements
Degree in Chemical, Process or Mechanical Engineering
Minimum 3-5 years experience in pharmaceutical or biotech industry
Strong knowledge of GMP requirements and qualification protocols
Experience with P&ID reviews and equipment specifications