CSV SME EXPERT- (closed)
Contract position-32 months
send resumes to: firstname.lastname@example.org
•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 Company 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
BS in Technology related field
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
• 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)