Subject: C&Q Engineer

C&Q Engineer:

The Commissioning and Qualification (C&Q) Engineer will be responsible for executing on-site C&Q Activities following ISPE/ASTM methodologies utilizing GDP, GEP & CGMP principles under the instruction of the SEPAM on site C&Q Lead.

They will be part of a team of Validation/Verification, Commissioning Engineers/ subject matter experts to perform the commissioning/qualification of equipment, utility systems, facilities and automation systems for a number of blue chip pharmaceutical clients.

We are searching for knowledge based co-operative individuals who have +5 Years industrial experience in a C&Q Engineer position with previous work experience in a GMP Environment & Large Scale Capital Project or Start-Up Projects in the Life Science Industry.

Scope of work:

 Prepare & Execute Impact assessments for Direct and Indirect impact systems in accordance with ISPE Methodologies Or risk assessments as per ASTM methodologies.

 * Perform Vendor Assessments.

 * Review FAT/SAT, attend FATS, and witness testing.

 * Prepare & Execute Design Qualification/ Design Reviews for direct impact systems/ critical to quality (CTQ) systems in accordance with SEPAM procedures/ site procedures.

 * Prepare & Execute IQ/OQ for direct impact systems/ Acceptance and Release reports for CTQ systems in accordance with SEPAM/Client Methodologies.

 * Prepare & Execute PQ for direct impact systems/ CTQ systems in accordance with SEPAM/Client Methodologies.

 * Review project documentation, specifications, datasheets, material certification etc. in order to leverage from Commissioning into Qualification activities.

 * Perform walk downs, witness/execute/review/approve/ test cases.

 * Review project documentation, specifications, datasheets, material certification etc. handover packs for Commissioning activities.

 * Generate/Review/Approve Commissioning (Green Tag & Blue tag) protocols for direct impact systems, indirect no impact systems.

 * Manage change controls and ensure close out.

 * Track protocol review approval, issue/deviation resolution, snag close out.

 * Update URS for project.

 * Generate TM for requirements through testing phase.