4. EDUCATION & EXPERIENCE:

• Bachelor’s Degree preferred
• Preferred to have 3-5 years of validation work experience in a GMP environment, including sterile; project management experience

1. ROLE PURPOSE:

This position is a member of the site leadership team and will manage the site commissioning and qualification, equipment qualification, and process and assay validation by ensuring the timely development, execution and coordination of all validation activities pertaining to facility, equipment and process in compliance with Quality System requirements, site procedures and regulatory requirements. This role will develop validation and Quality System documentation (e.g., IQ/OQ/PQ/SOP/Change Controls/Deviations/CAPAs etc.). This role will organize and schedule all validation activities ensuring project completion per schedule requirements.

2. KEY DUTIES & RESPONSIBILITIES:

• Manage and Direct the Validation Staff
• Guide, mentor and counselor validation staff
• Assure all validation work is compliant with regulatory guidance
• Assist with the training of the equipment operators
• Maintain the Company’s compliance with established Penn Life Sciences Standard Operating Procedures and specifications and Current Good Manufacturing Practices.
• Write, execute and coordinate commissioning, qualification and validation protocol testing.
• Schedule the execution of protocols
• Compile relevant commissioning/qualification/validation study data and generate summary reports to document the results of the studies.
• Aid in troubleshooting/impact assessment for atypical conditions during studies/ validations.
• Assist in the maintenance and development of any existing validation programs to ensure continued compliance with regulatory requirements.
• Provide scientific rationale/strategy for studies of new or modified GMP equipment and processes.
• Ensure all aspects of validation and qualification adhere to site and corporate policies and procedures, including safety and training.
• Review all errors, protocol deviations, and comments with the respective user department Management and QA and resolve discrepancies.
• Manage responsibilities and workload to assure accurate and timely data and reports.
• Complete any associated work order documentation.
• Review completed validation for accuracy and GMP compliance.
• Comply with FDA guidelines, Site and Corporate Policies for Data Integrity.
• Other duties as assigned.