Project Validation Lead

Valsource, Inc. seeks a Project Validation Lead for its 918A Horseshoe Pike, Downingtown, Chester County, PA 19335 location. The Project Validation Lead will have the following job duties:Responsible for activities related to the start-up, commissioning, qualification, validation (CQV) of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Collaborate with Engineering, Operations, Automation, Maintenance, and Quality departments to generate and obtain approval of project and system level life cycle documents: Generate and obtain approval of User Requirement Specifications (URS) to document direct impact and not direct impact requirements for Good Manufacturing Practice (GMP) utility,facility, and production systems. Conduct and Lead Test Plans to evaluate and identify testing methods to verify requirements and plans for leveraging testing from one phase to the next. Conduct and lead assessments of: Design Qualification (DQ) to ensure Direct Impact requirements are being met by the design of utility, facility, and production systems. Identify any gaps between the requirements and design and provide solutions for the stakeholders to review. Generate and obtain approval for System & Component Level Impact Assessments (SLIA & CLIA) to evaluate and document GMP and safety impact at a system and component level toplan the Commissioning, Qualification, and Validation (CQV) approach and strategy for utility, facility, and production systems. Generation and execution of protocols Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Verification (IV), Operation Verification (OV), Installation Qualification (IQ), Operation Qualification (OQ) Performance Qualification (PQ): Participate and Lead Factory Acceptance Testing (FAT) supplemental protocols for productions systems and verify all requirements are satisfied. Execute Direct Impact requirements verified in the FAT are completed in a GMP manner to ensure testing can be leveraged for Qualification. Generate, execute, and obtain approval of Installation/Operational Commissioning (IOC) protocols for utility, facility, and production systems to verify all safety and not direct impactrequirements are satisfied. Execute Direct Impact requirements verified in the IOC are completed in a GMP manner to ensure testing can be leveraged for Qualification. Generate, execute, and obtain approval of Installation/Operational Qualification (IOQ) and Performance Qualification (PQ) protocols for utility, facility, and production systems to verifydirect impact and critical requirements are satisfied. Generate and execute Computer System Validation (CSV) for Pharmaceutical equipment to meet 21 CFR Part 11 Regulation by the FDA. Conduct temperature mapping studies using specialized equipment such as Kaye Validator AVS including pre and post-calibration of thermocouples using iRTD and temperature baths. Generation, and supporting troubleshooting and close out of Qualification, discrepancies and deviations: Report for non-conformances with acceptance criteria and determine root cause and corrective actions. Generate requirements Trace Matrix to ensure Direct Impact requirements for URS are met through the various testing phases. Generate a Qualification Summary Report to outline CQV activities including resolution of non-conformances. Participate and lead the CQV efforts for: Lead Factory Acceptance Test (FAT) for GMP utility, facility, and production systems. Execute and review FAT results to evaluate if the system is acceptable. Escalate non-conformances and record on the project punch list. Lead mechanical completion process to ensure construction meets requirements for CQV and safety. Document findings on a punch list and generate solutions to non-conformances for stakeholders to evaluate. Participate in the startup of systems with the Vendor to ensure client's safety and CQV guidelines are being followed.Position Requirements:Master's degree in Pharmaceutical Science, Biomolecular Engineering or related Bio/Chemical Engineering plus three (3) years experience in the offered position or a related role. The position requires extended travel/relocation for several months or years to various unanticipated client sites throughout the U.S.To apply, send your resume via email to cbarnett@valsource.com .