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Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Robert Ciociola posted a job: "Job: IT CSV Lead Analyst 73-75,83 in Fort Washington, PA IT CSV Lead Analyst-Fort Washington 373-75,83 Contract position-6-9 Months Send resumes to: bciociola@covexllc.com Serve as the Validation/Compliance team lead for assigned projects. • Interprets complex technical quality requirements in specific CSV situations, such as validation of new systems, upgrades, changes or remediation, to set validation/compliance strategy. • Provides guidance, interpretation, and assures compliance with CSV related regulations, quality manuals, company policies, and procedures. • Responsible for authoring GxP computer validation and Part 11 related documentation (Assessments, Plans, FRS ect). • May be asked to develop, write and execute protocols, as needed • Interfaces with internal partners to analyze data and situations leading to sound decision making. • Supports site CSV related initiatives and remediation activities including Part 11 compliance. • Provide validation estimates, schedules, and projections to upper management. • Track and communicate progress of team assignments and milestones • Demonstrate mastery of the company’s policies for CSV, and SDLC and act as a Subject Matter Expert • Develop, maintain and report relevant metrics pertaining to performance of CSV team activities according to plan, highlight risk and assist and identifying and implementing risk mitigation activities. Education: BS in Technology related field Experience/ Technical Competencies: 3 to 5 years in pharmaceutical engineering, focusing on Computer System Validation. 3 to 5 years with pharmaceutical validation experience Strong background and experience in the Computer System Validation procedures, strategy and document development (i.e: manufacturing support systems, lab systems, PLC automation) Understand and background of enterprise wide systems and validation in GMP environment 1-3 yrs Project management experience Process Excellence Experience and certification Preferred Project management certification preferred Job Knowledge/Skillsets: • Technical writing of computer system and manufacturing equipment validations. Working with GxP systems in compliance to 21 CFR Part 210, 211, 11 (Electronic Records) and 820. • Knowledge in the following regulations and guidelines: > FDA Regulations (CFR Parts 210, 211, 11, 820 (Quality System Regulation)) > ISO Standards as applicable to Computer System Validation (ISO 9000-3) and Network Infrastructure (ISO 17799 – Security Standard) > PIC/S Guides as applicable to CGMP and Computer System Validation (Good Practices for Computerized Systems in Regulated GxP Environments) > GAMP 4 and recently revised GAMP 5, Guidelines and Testing of GxP Systems based on GAMP V-Model Framework > FDA Guidance on Software Validation (General Principles of Software Validation) > EU-GMP Annex 11 “Computerized Systems”, regulation Must have at least 3 to 5 years experience with Pharmaceutical Engineering, specializing in Computer System Validation. Independ... http://bull.hn/l/TPBF/2"

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