ObjectiveAs the Computer System Validation (CSV) Engineer for Perspective Therapeutics in Bloomingdale, IL, you will execute all software validation activities for a brand-new start-up GMP-compliant Radioligand Therapy (RLT) pharmaceutical manufacturing facility. You will ensure that all software is designed, installed, tested, and maintained in compliance with global regulatory requirements (cGMP, FDA, ISO, EU, etc.). You will follow the established CQV (Commissioning, Qualification, Validation) strategy for all systems used at the site, author governing documents (such as software-specific SOPs), manage vendors and internal stakeholders, and ensure successful transition from project execution to GMP operations. The CSV Engineer will amass all software SME knowledge, support the Engineering department as the site grows and matures, and play a key role in providing support for internal and FDA audits.Essential FunctionsFacility Start-Up: Execute all computer system validation start-up activities, including production, quality, safety, and facility software to support GMP radiopharmaceutical manufacturing. Establish software-specific standard operating procedures and workflows required to transition from start-up to steady-state manufacturing. Support initial regulatory inspections and audits associated with facility start-up and first product launches.CQV Strategy: Work with Project Managers and stakeholders to define and align qualification strategies with equipment lead times to ensure continuous CSV activities while adhering to aggressive timelines.Maintenance & Calibration: Understand equipment and regulatory requirements to ensure the software properly supports their functions. Provide subject matter expertise for production and facilities software (CMMS, EMS/BMS, etc.).Compliance & Validation: Ensure compliance with cGMP, FDA, OSHA, and other regulatory requirements through effective management of validation, change controls, CAPA, and deviation activities. Aid the site through regulatory inspections with zero observations. Author and execute Change Controls through the Quality Management System. Create and revise SOP documentation governing operation and facility practices.Qualification Improvements: Develop and implement robust software validation programs. Drive continuous improvement initiatives using lean manufacturing and Six Sigma methodologies to optimize efficiency.Cross-Functional Collaboration: Collaborate with key internal stakeholders such as Production, Quality, and Environment Health & Safety to support site operations in resolving engineering challenges and ensuring timely project execution.Vendor Management: Work with vendors for procurement, installation, and validation of new software, ensuring alignment with site objectives and compliance standards. Provide training and access management for third-party contractors and vendors.Equipment & Systems: Familiarize yourself with: Product Synthesizers, Lead-Shielded Isolators, Dispensing Systems, Dose Calibrators, Visual Inspection machines, Particle Counters & Air Samplers, BSCs & Fume Hoods, CMMS (BMRAM), BMS, EMS, Production software, Access Controls, etc.Documentation: Author supporting documentation for qualification activities: URSs, FRSs, DSs, FAT/SAT Protocols, IQ/OQ/PQ Protocols, Traceability Matrices, and related SOPs.Other: Provides support for internal and FDA audits.Qualifications
