New job

LinkedIn Following

Group: JOBS 2.0: Job Search Career Networking Staffing. Post Resume -Get Paid by Employers at Resumark .com Subject: Robert Ciociola posted a job: "Are you a good fit for this job? Computer System Validation SME 403 in Fort Washington, PA Computer System Validation SME-Fort Washington,PA Contract position-20 months send resumes to: bciociola@covexllc.com -Develop project plans to ensure requirements are collected within defined timelines, drive implementation with other system owners, develop metrics to report on progress and escalate issues as necessary. • Development of all applicable documents for CSV (Computer System Validation) and spreadsheets remediation per companyl standards and execution of remedaition activities. • Work with the site engineering, CSV assessors, and auditors to identify, assess, and remediate legacy automation systems. • Develop standard template to ensure effective and efficient CSV program • Work with QSE-9 (Facilities, utilities and Equipment) team to develop common documents that can be used for equipment qualifications that include CSV • Assist in maintaining manufacturing systems in a validated state as they relate to CSV automation systems. • Assist with execution of validation protocols • Travel to other manufacturing sites may be required Drive completion of activities and assist the team in issues resolution 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. Perform and lead gap assessment for a variety of GxP systems Assist in developing test scenarios and aprtnering with business and QA resources for execution and approval. 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 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 “Computeriz... http://bull.hn/l/T0N3/6"

Go see this job post »

Don't want to get activity notifications: Change your following people settings » Learn more about following people's activity This email was intended for Openings India (Owner, Recruitment India). Learn why we included this. © 2012, LinkedIn Corporation. 2029 Stierlin Ct. Mountain View, CA 94043, USA