Senior CSV Specialist – Data Integrity

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative shift (flexible hours based on business needs)

Position Overview

We are seeking an experienced Senior Computerized System Validation (CSV) Specialist to provide technical leadership and compliance support for computerized systems within a regulated pharmaceutical manufacturing environment. The selected candidate will be responsible for implementing and maintaining Computerized System Validation (CSV) and Data Integrity programs, ensuring that computerized systems supporting manufacturing, laboratories, packaging, utilities, facilities, and quality operations comply with applicable cGMP regulations, FDA requirements, 21 CFR Part 11, and established corporate and site procedures. This position will serve as a technical Subject Matter Expert (SME) for computerized system compliance, validation lifecycle activities, and Data Integrity, providing guidance on system implementation, risk assessments, remediation strategies, and regulatory inspection readiness.

Required Qualifications

• Bachelor's degree in science, Computer Science, Engineering, Information Systems, or a related technical discipline.
• Significant experience in Computerized System Validation (CSV) within pharmaceutical, biotechnology, or other regulated GMP environments.
• Thorough knowledge of cGMP regulations, FDA requirements, Data Integrity principles, and applicable electronic records regulations.
• Strong understanding of 21 CFR Part 11 requirements for electronic records and electronic signatures.
• Demonstrated experience developing and executing computerized system validation plans, protocols, qualification activities, and validation reports.
• Experience performing Data Integrity Assessments, computerized system risk assessments, and compliance gap evaluations.
• Knowledge of Software Development Life Cycle (SDLC) and computerized system lifecycle management.
• Experience supporting computerized systems used in pharmaceutical manufacturing, QC laboratories, packaging, utilities, facilities, and quality operations.
• Experience with system documentation, including URS, functional specifications, design specifications, data mapping, and traceability documentation.
• Knowledge of ALCOA+ principles, electronic data management, audit trails, and data governance requirements.
• Experience managing Change Controls, deviations, investigations, audit observations, and CAPA activities related to computerized systems.
• Ability to independently assess compliance risks, recommend remediation strategies, and provide technical guidance.
• Strong analytical, organizational, problem-solving, and technical writing skills.
• Excellent communication and cross-functional collaboration capabilities.

Preferred Qualifications

• Direct experience supporting CSV and Data Integrity programs within pharmaceutical manufacturing facilities.
• Experience validating MES, eBR, LIMS, laboratory systems, automation platforms, and enterprise manufacturing applications.
• Familiarity with manufacturing and laboratory computerized systems supporting sterile and non-sterile operations.
• Experience with audit trail reviews, system access controls, electronic signatures, data flows, and system interfaces.
• Knowledge of FDA guidance, GAMP 5, EU GMP Annex 11, and other applicable computerized system compliance standards.
• Experience supporting regulatory inspections and internal GMP audits.
• Experience implementing Data Integrity remediation programs and computerized system compliance improvements.
• Familiarity with manufacturing automation, IT infrastructure, and computerized system security requirements.

Key Responsibilities

• Lead and execute Computerized System Validation (CSV) activities for computerized systems supporting manufacturing, sterile and non-sterile operations, laboratories, packaging, inspection, utilities, and facilities.
• Develop, review, and execute computer system validation strategies, validation plans, protocols, test scripts, and supporting documentation.
• Establish and maintain an effective CSV program aligned with applicable regulatory requirements, corporate standards, and site quality procedures.
• Serve as the technical Subject Matter Expert (SME) for IT Compliance, Computerized System Validation, Data Integrity, and electronic records requirements.
• Ensure computerized systems are appropriately validated and compliant before being released for their intended use.
• Implement and maintain Data Integrity programs for new and existing computerized systems across manufacturing, laboratory, quality, and facility operations.
• Perform Data Integrity Assessments and computerized system risk assessments to identify vulnerabilities and ensure appropriate risk mitigation before system release.
• Evaluate system deficiencies, identify compliance gaps, and recommend corrective and preventive actions to address Data Integrity concerns.
• Develop and maintain computerized system data mapping documentation to ensure data flows, interfaces, and system functionalities align with operational and regulatory requirements.
• Ensure system lifecycle documentation, including User Requirements Specifications (URS), functional and design specifications, system drawings, data mappings, qualification protocols, and equipment manuals, remains accurate and current.
• Coordinate and execute periodic reviews of computerized systems in accordance with established schedules and regulatory expectations.
• Support Software Development Life Cycle (SDLC) activities, including the implementation and validation of electronic batch records (eBRs) and other manufacturing applications.
• Evaluate proposed system changes and recommend remediation strategies to maintain validated and compliant computerized systems.
• Support the implementation, configuration, qualification, and maintenance of new and existing computerized systems.
• Coordinate and ensure timely closure of quality incidents, investigations, audit observations, CAPAs, and Change Control records related to computerized systems.
• Provide technical recommendations and guidance to Manufacturing, Quality Assurance, QC Laboratories, Engineering, IT, and other cross-functional stakeholders.
• Communicate significant Data Integrity risks, compliance gaps, and potential regulatory impacts to site leadership and management.
• Support regulatory agency inspections and internal audits involving computerized systems, CSV, IT Compliance, and Data Integrity requirements.
• Monitor regulatory developments and industry best practices related to computerized systems, electronic records, and pharmaceutical Data Integrity.
• Promote continuous improvement and effective compliance practices across computerized system lifecycle activities.

Key Deliverables

The selected resource will be responsible for developing, reviewing, executing, maintaining, and/or coordinating:

• Computerized System Validation (CSV) strategies, plans, protocols, and reports.
• Data Integrity Assessments and computerized system risk assessments.
• User Requirements Specifications, functional/design specifications, and system lifecycle documentation.
• Data Mapping Assessments and computerized system data flow documentation.
• Installation, Operational, and Performance Qualification documentation, as applicable.
• Computerized System Periodic Reviews and compliance assessments.
• System remediation plans and Data Integrity corrective action documentation.
• SDLC and electronic batch record (eBR) validation documentation.
• Change Control, deviation, investigation, and CAPA records associated with computerized systems.
• Audit and regulatory inspection support documentation.
• System compliance assessments and validation gap analyses.
• Computerized system procedures, technical documentation, and supporting quality records.