We are seeking a dedicated Computer System Validation Specialist to oversee the full lifecycle of validation projects, ensuring compliance with regulatory standards and industry best practices. You will lead the development and implementation of validation protocols and documentation, manage cross-functional teams, and support compliance with GxP regulations.

Key Responsibilities:

• Lead full lifecycle validation projects for facilities, utilities, systems, and equipment.
• Develop and revise validation documents, including User Requirement Specifications, System Impact Assessments, Validation Plans, IOPQ protocols, and traceability matrices.
• Ensure compliance with GxP guidelines and industry standards throughout the validation process.
• Write and update SOPs for the Validation team.
• Maintain and organize validation documentation, including the Master Validation Plan.
• Keep the Systems Inventory current.
• Manage the implementation of critical systems and equipment, including computerized systems.
• Coordinate with project management, IT, and other departments and vendors to achieve project deliverables.
• Provide timely project updates and communicate expectations to team members and stakeholders.
• Report Quality Management System non-compliances to Senior Management.
• Plan and schedule project timelines and milestones.
• Develop and implement solutions to validation challenges.
• Present validation systems during audits.

Qualifications:

• Bachelor’s degree in Computer Science, Science, or related field.
• 5-7 years of experience in a GxP environment with expertise in facility, utilities, systems, and equipment (FUSE) in cellular manufacturing or similar industry.
• Test or validation certification is a plus.
• Strong knowledge of regulatory requirements, including GxP, 21 CFR Part 11, Annex 11, cGMP, and ISPE GAMP5.
• Familiarity with OSHA and safety regulations.
• Strong relationship-building, team collaboration, and problem-solving skills.
• Excellent technical writing, interpersonal, and communication skills.
• Proficiency in Microsoft Office and relevant software.