Computer System Validation (CSV) Lead

Job Title: Computer System Validation (CSV) Lead Location: Lancaster, PA Duration: 24 Months Job SummaryWe are seeking an experienced Computer System Validation (CSV) Lead to support the validation strategy and execution for a newly constructed Sterile Drug Product Clinical Manufacturing Facility in Lancaster, PA. This role will play a key part in supporting the transition and planned exit from the existing Sterile Drug Product Clinical Manufacturing facility by 2028.The CSV Lead will be responsible for developing and executing the CSV strategy in alignment with company policies while operating independently from the existing commercial organization. This position will report directly to the Automation Lead and work closely with Automation Engineers supporting facility and equipment system implementation.The ideal candidate will have strong expertise in CSV, automation systems, operational technology (OT), and GMP manufacturing environments, along with the ability to work independently in a fast-paced project environment.Key ResponsibilitiesLead the development and execution of the Computer System Validation (CSV) strategy for a new sterile drug product clinical manufacturing facility. Author, review, and execute CSV lifecycle documentation including: Validation Plans User Requirement Specifications (URS) Functional Specifications Risk Assessments IQ/OQ/PQ Protocols Traceability Matrices Summary Reports Support commissioning, qualification, and validation activities for GMP computerized systems and automation platforms. Collaborate with Automation, Engineering, Quality, Manufacturing, and IT teams to ensure compliant implementation of computerized systems. Lead deviation investigations and resolve technical issues related to validation activities and protocol execution. Support execution-phase validation activities throughout 2027. Ensure validation deliverables align with company policies, regulatory requirements, and industry standards including GAMP5 and 21 CFR Part 11. Participate in testing and troubleshooting of: Field I/O Instrumentation Control systems SCADA/HMI platforms Network and communication infrastructure Support validation of independent control platforms associated with: Robotic isolator and filling lines Lyophilization systems Formulation and wash isolators Autoclaves Equipment wash systems Door interlocking systems Work independently while managing multiple priorities in a dynamic project environment. Provide technical leadership and mentorship related to CSV best practices. Required QualificationsBachelor’s degree in Engineering, Computer Science, Automation, Life Sciences, or a related technical discipline. 10–15 years of experience in Computer System Validation (CSV), Automation, or Validation Engineering within regulated pharmaceutical or biotech environments. Strong experience supporting GMP manufacturing facilities, preferably sterile drug product or aseptic processing operations. Hands-on experience authoring and executing CSV documentation and validation protocols. Strong knowledge of: GAMP5 21 CFR Part 11 Data Integrity principles CSA/CSV methodologies Experience working independently in large capital projects or greenfield environments. Excellent technical writing, troubleshooting, and communication skills. Ability to support flexible work schedules based on project timelines. Preferred Technical ExperienceAutomation & Control SystemsAVEVA System Platform Allen Bradley PLC Siemens PLC AVEVA PI Historian SCADA, HMI, and OIT platforms Alarm Management Systems Particle Monitoring Systems Operational Technology (OT)OT network infrastructure Industrial communications Instrumentation and control systems Field I/O testing and troubleshooting Manufacturing Equipment & SystemsRobotic isolators Filling lines Lyophilization systems Formulation isolators Wash isolators Autoclaves Equipment washers Door interlocking systems Validation ToolsKneat validation platform experience preferred