Validation Specialist

4 weeks ago


Langhorne, Pennsylvania, United States Penn Life Sciences Full time
Job Overview

Penn Life Sciences is seeking a skilled Validation Specialist to join our team. In this role, you will be responsible for 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.

Key Responsibilities:

  • Maintain the Company's compliance with established KVK Standard Operating Procedures and specifications and Current Good Manufacturing Practices.
  • Write, execute, and coordinate commissioning, qualification, and validation protocol testing.
  • 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.
  • Perform scheduled preventive maintenance, and instrument calibrations.
  • Document all instrument calibrations and equipment preventive maintenance.
  • Complete any associated work order documentation.
  • Review completed validation, PM, and calibration documentation for accuracy and GMP compliance.
  • Comply with FDA guidelines, Site and Corporate Policies for Data Integrity.
  • Other duties as assigned.


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