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Robert Ciociola posted a job:

"Know anyone for this job? Computer Systems Validation Specialist 231 in Lancaster, PA Computer Systems Validation Specialist Lancaster, PA 231 Contract position-24 Months Send resumes to: bciociola@covexllc.com Work with the site engineering, CSV assessors, and auditors to identify, assess, and remediate legacy building automation systems.• Develop standard template to ensure effective and efficient CSV • Work with QSE-9 team to develop common documents that can be used for equipment qualifications that include CSV • Assist in maintaining equipment automation systems in a validated state as they relate to GxP CSV automation systems.• Assist with execution of validation protocols 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 Must have at least 3 to 5 years experience with Pharmaceutical Engineering, specializing in Computer System Validation. Familiar with GxP systems. Fluent knowledge of GAMP 5, CFR Part 11 Compliance and CFR Part 210, 211 & 820 compliance. Independent worker .Strong organizational/facilitation/communication skills. Strong verbal, written and presentation skills. Strong skills in Interdependent partnering and influencing 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. Independent worker. Strong organizational/facilitation/communication skills. Strong verbal, written and presentation skills. Strong sills in Interdependent partnering and influencing. Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)" Travel: • Travel to other manufacturing sites may be required (<10%) Contract Length: 12/31/2014 http://bull.hn/l/V4W5/5"

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