Computer Validation Engineer IV

The incumbent will oversee and coordinate new projects related to validation deliverables and qualifications to ensure existing and new system installations meet all internal and external compliance requirements such as 21 CFR Part 11, EU GMP, and GLP requirements throughout the systems development life cycle.

This position works on moderately complex problems of diverse scope where analysis of data requires solid evaluation of identifiable factors.

• Work closely with GMP, GLP and IT business units to provide Computer System Validation Services to implement validated system and maintain the validated state of current systems
• Acts as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management for GMP/GLP systems.
• Applies and enhances existing computer system validation programs for the validation of new production and manufacturing /laboratory computer systems, including major capital projects and computer systems for both early phase and commercial phase.
• Ensure existing systems and new systems are compliant with all applicable regulations based on their applicable use at Celldex
• Coordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems
• Develop Standard Operating Procedures and policies to support computer validation systems for GMP/GLP
• Develop training materials and provide training to Celldex staff related to the computer validation systems for GMP/GLP
• Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and IT
• Manages multiple simultaneous validation, revalidation, and change control activities
• Develop validation project management deliverables as needed such as plans, qualification protocols, gap assessments, risk/impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change control / change management and continuous improvement for GMP/GLP
• Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes for GMP/GLP systems
• Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state for GMP/GLP systems
• 8+ years applicable work experience in cGMP/GLP related industry