Computer Validation Engineer III/IV

Overview
The CSV 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 and EU GMP 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.

Responsibilities

• Work closely with all 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
• 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
• Ensure existing systems and new systems are compliant with all applicable regulations based on their applicable use at Celldex
• Develop Project Validation Plans, Installations Qualification Protocols, Operational Qualification
• Protocols, Performance Qualifications Protocols, Trace Matrices and Validation Summary Reports for new applications
• Coordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems
• Develop Standard Operating Procedures to support computer validation systems
• Develop training materials and provide training to Celldex staff related to the computer validation systems
• Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process
• Development, Facilities, and Regulatory Affairs
• Manages multiple simultaneous validation, revalidation, and change control activities
• Develop validation project management deliverables as needed such as 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
• Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes
• Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state

Qualifications

• Proven track record in validation and qualification of complex computer systems
• Demonstrable knowledge of GxP environs such as cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards
• Excellent writing and communications skills
• Excellent people and interpersonal skills

Education/Experience:

• 5+ years applicable work experience in cGMP related industry
• Bachelor’s degree in a technical discipline (computer or biological sciences), or equivalent
• Demonstrated experience coordinating validation projects in validated and regulated environments
• Demonstrated experience reviewing / evaluating legacy systems, and provide gap reports/assessments per each system per 21 CFR Par 11 compliance