Computer System Validation (CSV) Lead- Pharma (Hybrid Lawrenceville, NJ)

We are seeking a Computer System Validation (CSV) Lead for our global Pharmaceutical client. This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area. This role will be supporting validation leads to help ensure the required deliverables and testing are complete according to the CSV SOP. Experience with current digital validation tools is required, use of AI as an accelerator is a plus.This is a 40-hour per-week, 7-month contract (extensions possible), 50% onsite at the client s office in Lawrenceville, NJ (8am 5 pm).This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.ResponsibilitiesSupport creation, review, and approval of all CSV deliverables for custom in-house solutions. Maintain close communication with stakeholders and team members to keep apprised of CSV needs, interpretation of requirements, impacts on compliance of an application, project status, and other relevant issues Ability to create documents to an existing document standard Obtain and respond to review by Business, IT, and Quality stakeholders Follow SOPs and industry best practices Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project. Experience with electronic document management systems (e.g. Qumas, SharePoint etc.); application development and lifecycle management (e.g. ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow) Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members. Familiarity with using AI as an accelerator for creation and review of documents and testing. Requirements8 10+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments 5+ years of experience in Data Integrity/ALCOA+ principles 5+ years of experience with CSA principles 5+ years of experience with technical writing Working knowledge of GMP, GLP, and GAMP 5 principles Strong understanding of FDA regulations, ICH guidelines, and EU Annex 11 (as applicable) Experience developing, executing, and reviewing: Validation protocols and reports, Risk assessments (FMEA, impact assessments), SOPs, deviation investigations, and CAPAs Ability to support regulatory inspections and audits (FDA, EMA, internal, or client audits) Strong technical writing skills with attention to detail and data integrity Proficiency with common pharmaceutical documentation systems and tools (e.g., EDMS, change control systems) Cross-functional experience in one or more regulated areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired. Bachelor s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific or technical discipline. Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Computer System Validation (CSV) Lead role).Please feel free to forward this project opening to others who may be interested.Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.Compensation: $77/hr. - $79.35/hr.