Overview

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.

Responsibilities

• 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

Qualifications

• 8+ years applicable work experience in cGMP/GLP 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
• Experience with network qualification required
• Experience with ERP system qualification required
• Experience with Veeva products required
• Successful implementation of ERP, Veeva, lab, production systems required.
• 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, 15 and GAMP standards
• Experience with qualification of AI preferred
• Experience with qualification of lab software systems required
• Excellent writing and communications skills
• Excellent people and interpersonal skills
• High level of collaboration and working on and leading teams

Compensation StatementThe expected base salary for this position is: $101005.00 to $131175.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page