CQV Engineer Job

CQV Engineer is needed to perform the following duties:

· Commissioning, Qualification and Validation of Tangential Flow Filtration Systems, Chromatography Skids, Isolators, Autoclaves, Freeze Thaw Units, Refrigerators, Fill Units, Inspection Machine Lines and Packaging Machine. Performing SAT, IQ, OQ and PQ. Creating Batch Production Records (BPR).

· Performed data collection during validation of equipment following cGMP practices to identify any trend in the data. Reviewed data during monitoring phase to identify upper and lower limits of trends and address deviations.

· Handling GMP facilities such as HVAC systems, Air Handling Units, utilities such as Compressed air Piping, Heating water and steam generators and equipment including Autoclaves, Lyophilizers, Vial fillers, Incubators, air handling units, depyrogenation tunnels. etc.

· Draft/Review SOPs, Risk Assessments, Administration the Change Control Review Board meeting, Report generation and providing metrics, assisted with the QMS steps for Change Control, Validation and Qualification Reports, Equipment Technical Manuals, QC Lab worksheets, Logbooks in order to investigate deviations. Utilizing change management systems to update Quality documents and procedures, Handling Quality Management System (QMS).

· Project Management task including Validation Periodic Review that involves reviewing Validation Protocols, SOPs, Change Control Request forms, Preventative Maintenance and Work Orders. Tracking and updating the project timelines/milestones. Performing Gap Analyses and Risk assessment of utilities and equipment using FMEA.

Bachelor's Degree is required in Mechanical Engineering or Engineering Management.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave