Computer Validation Engineer IV

About the role

Celldex, a biotechnology company developing antibody-based immunology therapies, is hiring a Computer Validation Engineer IV in Fall River, Massachusetts. The incumbent oversees and coordinates new validation projects so that existing and new system installations meet internal and external compliance requirements such as 21 CFR Part 11, EU GMP and GLP throughout the systems development life cycle. The role involves moderately complex problems requiring solid evaluation of identifiable factors.

Key responsibilities

• Work with GMP, GLP and IT business units to provide computer system validation services and keep systems validated.
• Act as quality contact and primary SME for computer system validation and quality risk management for GMP/GLP systems.
• Apply and enhance validation programs for new production and laboratory computer systems, including major capital projects and early-phase and commercial systems.
• Ensure systems comply with applicable regulations based on their use at Celldex.
• Coordinate incident management and the corrective and preventative actions needed to maintain validated systems.
• Develop standard operating procedures and policies, training materials and training for computer validation systems.
• Manage multiple simultaneous validation, revalidation and change control activities, and develop deliverables such as plans, protocols, gap assessments, risk assessments, validation plans and reports.
• Evaluate changes to the validated state through change control and support system administration and maintenance procedures.

Required profile

• 8+ years of applicable work experience in a cGMP/GLP-related industry.
• Bachelor's degree in a technical discipline (computer or biological sciences) or equivalent.
• Demonstrated experience coordinating validation projects in validated, regulated environments and reviewing legacy systems with gap reports per 21 CFR Part 11.
• Proven track record validating and qualifying complex computer systems.
• Knowledge of GxP environments, including 21 CFR Part 11, EU GMP Annex 11 and 15, and GAMP standards.
• Excellent writing, communication, collaboration and leadership skills.

Required skills

• Network qualification
• ERP system qualification
• Veeva products
• Successful implementation of ERP, Veeva, lab and production systems
• Qualification of lab software systems; experience with AI qualification preferred

What we offer

• Expected base salary of $101,005 to $131,175.
• Annual discretionary bonus, long-term incentive, 401(k) with employer contribution, health care and other insurance benefits, paid holidays, vacation and sick days.