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Robert Ciociola posted a job:

"Job: CSV Subject Matter Expert in Lancaster, PA CSV Subject Matter Expert Lancaster, PA Contract Length: 32 months send resumes to: bciociola@covexllc.com Job Description: •Work with QSE-6 VALIDATION team to develop required documentation for evidence binders in support of the Consent Decree Work plan • Development of all applicable documents for CSV (Computer System Validation) remediation per McNeil standards • 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 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 Process Excellence Experience and 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. 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: <10% http://bull.hn/l/NI28/2"

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