Computer Systems Validation Engineer

Job Description

*Work with client Validation team to develop required documentation for a Consent Decree Work plan
* Development of all applicable documents for CSV (Computer System Validation) remediation per Client standards
* Work with the site engineering, CSV assessors, and auditors to identify, assess, and remediate legacy automation systems.
* Develop standard templates to ensure effective and efficient CSV program execution.
*Develop IQ/OQ/PQ: Installation Qualification, Operational Qualification, Performance Qualification
* Work with Facilities, utilities and Equipment teams 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

Experience/Technical Competencies

3 to 5 years in pharmaceutical Computer System Validation.
Strong background and experience in the Computer System Validation procedures, strategy and document development (manufacturing support systems, lab systems, supply chain systems, PLC automation) GMP compliance knowledge

* Technical writing of computer system and manufacturing equipment validation. Working with GxP systems in compliance to 21 CFR Part 210, 211, 11 (Electronic Records) and 820.
* Knowledge in the following regulations and guidelines:

Must have at least 5 years experience with Pharmaceutical Engineering, specializing in Computer System Validation.

Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)
Travel to other client's manufacturing facilities may be a possibility

Experience with the following systems is highly desired

Waters Empower, Smartlab, versatile, QMS - Quality Management Systems, EtQ, EDM - electronic data monitor, MES - manufacturing execution systems, EDMS - electronic document management system, Oracle Clinical, content management systems, CMS, SharePoint, CranSoft, SAP

Core Competencies

CSV - computer system validation, 21 CFR Part 11, Part 210, Part 211, Electronic Records, Part 820, pharmaceutical IT systems, manufacturing execution systems, content management systems, electronic

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