Senior CSV Engineer — GMP/GLP System Validation

Celldex Therapeutics, Inc.; Fall River (MA); On-site; USD 101,000 - 131,000; Full time

Benefits offered by this job

401(k) plan

Health care

Paid holidays

Vacation

Sick days

Long-term incentive

Job summary

Celldex Therapeutics, Inc. seeks a seasoned Computer System Validation (CSV) Specialist to oversee validation deliverables for GMP/GLP systems across the life cycle.

You will coordinate validation projects, develop SOPs, and train staff while ensuring CFR 21 Part 11, EU GMP Annex 11, and GAMP-aligned practices. The role requires strong writing, communication, and cross-functional collaboration on complex manufacturing and lab systems.

Qualifications

• Bachelor's degree in a technical discipline, or equivalent.
• 8+ years in cGMP/GLP environments coordinating validation projects.
• Experience with CFR 21 Part 11 compliance and legacy system gap reports.

Responsibilities

• Provide CSV services to validate GMP/GLP systems and maintain validated state.
• Act as SME for CSV and Quality Risk Management for GMP/GLP systems.
• Develop validation programs for new and existing production/lab systems.
• Ensure compliance with applicable regulations based on system use.
• Coordinate incident management and corrective/preventive actions.
• Develop SOPs, training materials, and provide training to staff.
• Collaborate with Quality, Manufacturing, Process Development, Facilities, and IT.
• Manage multiple validation, revalidation, and change control activities.
• Produce plans, protocols, risk assessments, user requirements, specs, TRs, and summary reports.

Skills

Excellent writing

Excellent communication

Cross-functional collaboration

Leadership

Problem solving

Education

Bachelor's degree in computer or biological sciences

Tools

Veeva

ERP systems

Network qualification

Validation tools

Job description

Celldex Therapeutics, Inc. seeks a seasoned Computer System Validation (CSV) Specialist to oversee validation deliverables for GMP/GLP systems across the life cycle.

You will coordinate validation projects, develop SOPs, and train staff while ensuring CFR 21 Part 11, EU GMP Annex 11, and GAMP-aligned practices. The role requires strong writing, communication, and cross-functional collaboration on complex manufacturing and lab systems.