IT CSV Engineer

📋 Description

• Lead validation initiatives for Manufacturing (MFG), Quality Control (QC), enterprise, and PP&D systems as part of the Sandoz remediation project.

• Ensure compliance with client specifications, regulatory standards, and project deadlines.

• Collaborate with cross-functional teams to implement intricate Computer System Validation (CSV) projects, including both remediation and the introduction of new systems.

• Formulate validation strategies and create validation documents such as validation master plans, data migration plans, protocols, reports, and resolutions for discrepancies.

• Oversee and improve validation testing processes, ensuring that risk-based validation methods are in line with current FDA Computer Software Assurance (CSA) principles and GAMP5 practices.

• Standardize and refine CSV framework templates and procedures to promote continuous improvement efforts.

• Support and manage risk management activities, including risk assessments and gap remediation initiatives.

• Maintain compliance and the validated status of all GxP systems.

• Manage external CSV consultants and supervise their contributions to CSV projects.

• Act as a subject matter expert (SME) in Data Integrity, CSV lifecycle management, and adherence to global regulatory requirements.

• Take ownership of CSV-related deviations and CAPAs, overseeing remediation activities linked to CSV and Data Integrity.

• Collaborate with IT to establish backup/restore protocols, disaster recovery plans, compliance with data retention schedules, and infrastructure qualification necessities.

• Assist business and technical stakeholders in developing requirements and specifications for computerized systems utilized in GxP operations.

• Supervise the creation and execution of IQ, OQ, and PQ test scripts.

⛳️ Requirements

• Extensive experience in GxP computer systems validation and adherence to compliance standards.

• Comprehensive understanding of GxP regulations and CSV/CSA principles, including but not limited to 21 CFR Part 11, Annex 11, GAMP 5, and Data Integrity.

• Familiarity with Quality Risk Management (ICH Q9) and its implementation in CSV.

• A minimum of 5 years of experience in GxP CSV roles.

• Profound understanding of validation/qualification principles within pharmaceutical quality systems.

• Strong technical writing capabilities for validation documentation and compliance reports.

• Exceptional communication skills (both verbal and written) with the ability to engage effectively across various organizational levels and functions.

🏝️ Benefits

• Discretionary annual bonus

• Comprehensive benefits package including Medical, Dental, and Vision

• Short-term and long-term disability coverage

• Company-paid basic life insurance

• 401k with company matching

• Flexible work arrangements

• Generous paid time off and holidays

• Wellness and transportation benefits