New Jersey Area
Computer System Validation (CSV) professional author, execute, review and summarize activities related to the validation of computer systems and define/ establish controls to ensure regulatory compliance. This involves supporting regulated systems from a compliance perspective throughout their life cycle including planning, requirements, specification, design, test, install and verification.
Essential Duties and Responsibilities
- Validating Enterprise Resource Planning (ERP) systems (Ex. Sage, SAP, JD Edwards, Bpics)
- Review and evaluate computerized system validation (CSV) strategies, policies, standards, processes, SOP's and other documents and provide guidance and counsel as needed.
- Develop and perform all CSV activities, and documentation requirements including plans, risk assessments, function requirements, configuration specifications, testing(IQ/OQ/PQ), change controls, trace-ability matrix, qualification protocols, validation and compliance reviews.
- Track software validation activities and author simple weekly progress reports.
- Develop and complete deliverable as needed and in line with project/business objectives.
- Must be willing to travel to client sites, when applicable.
- College degree (Preferably Biomedical or Chemical Engineering) or equivalent work experience; 5+ years of system validation experience in an FDA or related regulatory environment is needed.
- Seasoned in SDLC for Life Sciences, strong insight and understanding of cGMP and GAMP industry practices in addition to 21 CFR Part 11, data integrity, SOP authoring experience.
- Experience with MS Project, SmartSheet and/ or flow charting software a plus
- Effective organization, communication and interpersonal skills and the ability to manage priorities in a time sensitive environment.
- Proficiency using computer software and systems related to performing system/equipment activities; experience with systems (e.g. SAP, Salesforce, Documentum, Trackwise, or specific MES/ERP/LIM system(s))