This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Specialists.
This position will specifically be accountable for Continuing Validation/Qualification for Laboratory, Facilities and Equipment at the IOPS site.
• Leads cross-functional teams in developing Validation best practices, standards and guidelines which includes exploring new techniques, methods and other industry practices.
• Leads projects by developing appropriate plans, schedules, resource loading and other project deliverables as required Execution of validation projects and overseeing Validation projects as well as junior-level staff. Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols and writing reports of validation results.
• Reviews and approves Validation protocols and summary reports generated by the Validation staff against standard operating procedures and policies as well provides guidance to Validation staff writing protocols and final reports
• Prepares equipment for qualification studies and executes qualification and validation studies according to approved protocols and SOPs
• Leads team of Validations specialist who investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Approves various documents relating to area function, including those listed above.
• Provide direction and assign work to Validations Specialists to meet goals and timings
• Coordinates prioritization of activities with area management.
• Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
• Reviews internal and external requirements and implements required processes, as needed, to meet expectations regarding Quality.
• Participates in regulatory and customer activities.
• Collaborates with functional departments to resolve issues.
• Manages projects and prepares status reports.
• Develops and implements program requirements for continuing qualification for:
• Laboratory Equipment.
• Facilities (HVAC, Utilities.)
• Equipment (including SIP and Cleaning Validation requalifictaions.)
• Requires a BS/BA in Engineering, Chemistry, or Life Sciences.
• A minimum of 6+ years of related experience within the field.
• May consider substituting relevant experience for education.
• Experience leading, supervising, or managing others required.
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