1.Prepare qualification (Installation, Operational and Performance) protocols and reports for new or modified Facilities, Manufacturing and Packaging Equipment, Product Contact and Non-Product Contact Utilities, HVAC and CTUs.
2.Prepare Cleaning and Process validation protocols according to internal and external requirements.
3.Execute qualification, cleaning and process validation tests in accordance to approved protocols, procedures and guidelines.
4.Analyze cleaning and process validation test data to determine whether systems or processes have met validation criteria.
5.Write process and cleaning validation final reports that present, summarize and offer conclusions based on the validation test results.
6.Participate in investigations related to qualification and/or validation activities to identify root cause of deviations.
7.Prepare documentation such as maintenance, process and cleaning batch records and/or instructions required to support qualification and validation activities.
8.Provide trainings to personnel supporting qualification and validation activities.
9.Active participation in Project meetings, as needed.
10.Comply with established site procedures and guidelines for GMP, Safety and Environmental.
1.Bachelor degree in Science, Engineering or related field.
2.Experience with the following: process equipment, packaging equipment, cleaning systems (CIP), thermal mapping, critical utilities (Nitrogen, Compressed Air, HVAC, Water Systems), cleaning and process validation, planning and execution.
3.Work experience in pharmaceutical cGMP regulated environment.
1.Ability to work independently and effectively under pressure, handle multiple tasks and meet deadlines.
2.Excellent English technical writing skills and strong communication skills; able to interface with all levels of the organization including team members, operators and managers.
3.Statistical knowledge preferred.
1.Available to work extended and irregular shift hours
2.Available to work in production, laboratory, warehouse facilities under construction.
3.The use of personal protective equipment is required (shoes, safety glasses, helmet, production gowning, etc.).