Process CSV Validation Engineer

Job Description

Job Description:

The CSV Validation Engineer III will be responsible for oversight of all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. This individual will provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated, and conduct impact assessments of proposed changes to computerized systems. 

• Will provide the necessary oversight of system to ensure that all GxP computerized systems are maintained in a validated state throughout their lifecycle.
• Additionally, the individual will focus on ensuring consistent policy administration, implementing key improvement initiatives, and solving compliance issues.
• Serve as the validation expert for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation.
• Perform and/or direct GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11, Annex 11, and Data Integrity.
• Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and our company's quality policies and procedures.
• Validation projects will include manufacturing systems, lab systems, facilities systems, and steady state activities around these applications. Engineer should have experience in this field
• Participate as the validation representative in project team activities and process design to ensure cGMP compliance and interdepartmental consistency within the validation program.
• Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.

Qualifications 

• Technical Degree or B.S. Degree in Engineering. Degree in Computer Sciences, Computer Engineering is highly preferred.
• Must have a minimum of five (5) years’ experience in a pharmaceutical GMP environment. Must have a minimum of three (3) years direct CSV validation experience in Pharma/BioProcess domain
• Knowledge of IT Control methodologies, including GAMP5 and solid understanding of GxP guidance, including 21 CFR Part 11, Annex 11, and Data Integrity.
• Knowledge in computerized system lifecycle activities, CSV, and IT controls in a regulated environment.
• Solid Knowledge of validation of cGMP automation/computerized systems is preferred within an EMA/FDA regulated environment.
• Hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.  Experience with system validation across GxP landscape, specifically GMP applications.
• Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g., FDA, MHRA Data integrity guidelines, etc.) around quality systems and computer system validation in Biotech and/or pharmaceutical industry
• Excellent communication and listening skills
• Knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.