The Validation Technician is responsible for the support, monitoring and execution of validation plans (process, cleaning, equipment and utilities). The Validation Technician will prepare protocols and reports as needed.
-Prepare, execute, and summarize qualification / validation protocols (IQ, OQ, PQ, and PPQ) for pharmaceutical equipment (manufacturing/packaging/utilities/facilities), processes, and products.
-Coordinate Calibration Program and perform calibration procedures.
-Coordinate the Continuous Process Verification Program according to applicable schedules.
-Coordinate and provide validation support activities to the Technical Services, Operations and Quality departments as required.
-Work independently, but also participate in project teams to handle development of system reviews for validation, and troubleshooting activities to accomplish project goals.
-Apply statistical concepts and data analysis for qualification/validation projects.
-Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.
-Support validation activities during off shift hours, if required
Working hours: 8:00 AM - 5:00 PM
-Must possess mechanical aptitude along with basic mechanical skills.
-Must possess excellent written and verbal communication skills, interpersonal skills, strong work ethic, organizational skills and a proficient knowledge of Microsoft Office including Word, Excel, Power Point, and Outlook. -Must be detailed-oriented and have the ability to perform multiple projects/tasks simultaneously.
Minimum of an Associate???s degree (or equivalent) and 0-2 years of experience.
However, a combination of experience and/or education will be taken into consideration.
Applicant should have familiarity with manufacturing and/or packaging operations (validation procedures preferred).
If you are interested please email resume.
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