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Validation Lead III
Ref No.: 15-03770
Location: Allston, Massachusetts
 Quality oversight of new facility and utility design, architecture and construction, including associated AIR Project documentation);
Quality oversight of cycle development (cleaning and sterilization) protocols and reports;
Review and approval of AIR technical reports; GMP drawing sets; decommissioning protocols or plans, engineering studies; design specifications; project change forms; procedures, controlled documents including Master Production and Control Records; change controls; as they pertain to the AIR Program;
Review and approval of AIR validation Plans, protocols, and summary reports; commissioning and qualification plans, protocols, and summary reports; requalification protocols and summary reports; commissioning test packs including automation test packs, protocols and summary reports; as they pertain to the AIR Program;
Review and approval of AIR equipment and facility user requirement specifications; system impact and critical aspect analysis; design qualification protocols and summary reports; IQ, OQ, IOQ checklists; performance qualification protocols and reports; CCR validation assessment concurrence; computer system validation plans and testing protocols, summaries, reports, trace matrices.
Participation in program reviews and risk assessments 
Familiarity with the following areas:
Biopharmaceutical process equipment
Cell Culture or Protein Purification processes
Media and Buffer Manufacturing processes
ISO classified environments and environmental monitoring programs
Critical utilities such as WFI, purified water, clean steam and HVAC and other critical utility systems
Calibration programs
Change control
Engineering drawing review, including P&IDs
Commissioning, IQ, OQ, PQ and validation review

9 years of CGMP experience
3 years of experience in Quality Assurance Validation related to Quality support for ongoing manufacturing operations

Education:
Bachelor of Science in Science or Technical field