Senior CQV Engineer Job

Senior CQV Engineer is needed to perform the following duties:

· Perform 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.

· Qualification of Automated Inspection Machine Lines and Packaging Machine. Performing SAT, IQ, OQ and PQ. Creating Batch Production Records (BPR).

· Handle GMP equipment including autoclaves, Lyophilizers, Vial fillers, Incubators, air handling units, depyrogenation tunnels.

· 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 tracking and updating the project timelines/milestones. Performing Gap Analyses and Risk assessment of utilities and equipment using FMEA.

· Perform temperature mapping on freezers and refrigerators.

· Draft/Review IOQ protocols for replacing old equipment with new.

Bachelor’s degree is required in Computer Science or Computer Engineering or Computer Information Systems OR education + experience which is equivalent to a Bachelor’s degree in Computer Science or Computer Engineering or Computer Information Systems.

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