Commissioning And Qualification Engineer
through Phoenix business solution llc in
Commissioning And Qualification Engineer Full time through Phoenix business solution llc in Ireland
Job highlightsPosted on October 16, 2016
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 Client 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 Client procedures/ site procedures.
Prepare & Execute IQ/OQ for direct impact systems/ Acceptance and Release reports for CTQ systems in accordance with Client Methodologies.
Prepare & Execute PQ for direct impact systems/ CTQ systems in accordance with 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.
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