1.Prepare Cleaning and Process validation/qualification protocols according to internal and external procedures and guidelines.
2.Execute cleaning and process validation/qualification and procedures tests in accordance to approved protocols, procedures and guidelines.
3.Coordinate process and cleaning validation/qualification execution activities with the required areas, this includes but is not limited to the production and laboratories.
4.Monitor the proper execution of qualification and validation activities in accordance to approved protocols, procedures and guidelines.
5.Analyze cleaning and process validation test data to determine whether systems or processes have met validation criteria.
6.Write process and cleaning validation reports that present and summarize execution and offer conclusions based on the validation test results.
7.Proactively monitor the completion of required cleaning or process validation activities to ensure they meet the established due dates.
8.Participate in investigations related to qualification and/or validation activities to identify root cause.
9.Prepare other documentation such as maintenance, process and cleaning batch records and/or instructions, as required, to support qualification and validation activities.
10.Provide trainings to production and laboratory personnel supporting qualification and validation activities.
11. Active participation in Project meetings, as needed.
12.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), 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.The use of personal protective equipment is required (shoes, safety glasses, helmet, production gowning, etc.)