Computer Systems Validation (CSV) Specialist/Validation Specialist

Overview: The Computer Systems Validation (CSV) Specialist/Validation Specialist ("CSV Specialist") is an onsite role based at SOFIE's Center of Excellence in Totowa, New Jersey, a 21 CFR 211 and EudraLex Volume 4 compliant manufacturing facility supporting the production of therapeutic radiopharmaceutical products. This position provides hands-on CSV support for site-based and network-based (when applicable) GMP computer systems. As the CSV Specialist develops deep understanding of software and applications performing the duties of this role, it is also expected that the CSV Specialist will perform CS auditing, act as an application administrator for some systems and provide general IT support for systems for which the specialist has developed expertise. It is expected in this role that the CSV Specialist can generally assist with validation of the instruments that the software and microprocessor support. The CSV Specialist is a member of the NJ5 Engineering group and will report to the Directo RCM/RSO. The role focuses on execution and support of validation activities rather than overall program ownership, while still requiring strong technical judgment and regulatory understanding. Essential Duties and Responsibilities Compensation Range: $95,000 - $105,000 Essential Duties and Responsibilities • Drafting and maintaining CSV deliverables such as Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports. • Developing and executing test plans, test scripts, and User Acceptance Testing (UAT) under approved validation strategies. • Supporting the development and maintenance of procedures related to Computer System Validation, Data Integrity, and 21 CFR Part 11 and EudraLex Volume 4 Annex 11 compliance. • Assisting with qualification of computerized systems impacting cGMP operations using a risk-based (GAMP 5-aligned) approach. • Working cross-functionally with Quality Assurance, IT, Engineering, Facilities, Manufacturing, and QC to support validation of site systems. • Providing CSV input during system implementation, upgrades, and configuration changes to ensure compliance with validated states.

• Gathering User Requirements and preparing Risk Assessments with cross-functional groups.
• Executing validation activities in accordance with approved project timelines and change control

requirements. • Assisting in evaluation of proposed changes to validated systems and recommending appropriate revalidation activities • Supporting system lifecycle activities, including periodic reviews and system retirements, and including annual CS auditing.

• Supporting CAPAs, deviations, discrepancies, and change controls related to computerized systems
• Maintaining documentation in a compliant, inspection-ready state.
• Serving as a CSV subject matter resource during regulatory inspections, as needed.
• Serving as a CSV resource for application integrations at SOFIE.
• Serving as an application/system administrator as assigned.
• Performing other related duties as assigned

Qualifications

• Bachelor's degree in Computer Science, Life Sciences, Engineering, or a related technical discipline
• 3+ years of experience in Computer Systems Validation within a GMP-regulated pharmaceutical or

radiopharmaceutical environment. • Working knowledge of FDA 21 CFR Part 11, 21 CFR 211 and/or 21 CFR 212, and EU Annex 11 requirements.

• Hands-on experience authoring and executing CSV documentation.
• Familiarity with risk-based validation methodologies (e.g., GAMP 5)
• Experience supporting or validating systems used in manufacturing, QC laboratories, utilities, or facilities

(e.g., LIMS, BMS, EMS, CMMS). • Strong written and verbal communication skills, with the ability to work effectively in cross-functional teams.

• Experience supporting audits, inspections, change controls, and CAPAs is preferred.
• Experience with Laboratory Information Management Systems (LIMS) is a plus. SOFIE