Lead Senior Computerized System Validation (CSV) Consultant

Job Description:
We are seeking an experienced Senior Computerized System Validation (CSV) Consultant to lead validation strategy, ensure compliance with regulatory standards, and manage validation teams within a GXP and GMP-regulated pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in Manufacturing Execution Systems (MES), Delta V, and laboratory system validation, with strong leadership and project management skills.
Responsibilities:

• Develop and manage CSV strategy and execution for IT systems used in pharmaceutical manufacturing, including MES, Delta V, and laboratory systems.
• Lead and manage a team of CSV engineers, providing guidance and oversight on validation projects.
• Ensure regulatory compliance with GMP, GXP, GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
• Define and implement risk-based validation approaches, assessing system risks, critical functions, and mitigation strategies.
• Develop, review, and execute validation protocols (IQ, OQ, PQ) to ensure system reliability, data integrity, and regulatory compliance.
• Collaborate with cross-functional teams (IT, Quality Assurance, Manufacturing) to align validation activities with business and regulatory requirements.
• Prepare and maintain validation documentation, including validation plans, reports, traceability matrices, and SOPs.
• Conduct internal audits and support regulatory inspections, ensuring compliance with industry standards.
• Provide training and mentorship to junior validation engineers and cross-functional teams on CSV best practices and compliance requirements.
• Manage project timelines, budgets, and resources to ensure timely delivery of validation activities.

Requirements:

• Bachelor's degree in Computer Science, Engineering, or a related field.
• Extensive experience in Computerized System Validation (CSV) for IT systems in Life Sciences, with a deep understanding of regulatory frameworks (GXP, GMP, GAMP 5, FDA 21 CFR Part 11, EU Annex 11).
• Proven experience in developing and executing validation protocols (IQ, OQ, PQ) for systems such as MES, Delta V, laboratory systems, and ERP systems.
• Strong knowledge of pharmaceutical or biologic manufacturing processes, equipment, and regulations.
• Experience conducting risk assessments, impact analyses, and validation lifecycle management.
• Ability to manage multiple projects and lead validation teams, ensuring strict adherence to regulatory and business requirements.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Detail-oriented mindset with a focus on accuracy, compliance, and documentation in a regulated environment.
• Ability to manage project budgets, resources, and validation timelines while ensuring compliance and operational efficiency.

Preferred Qualifications & Certifications:

• GAMP 5.
• PMP (Project Management Professional) Certification (preferred).

Technical Expertise:

• Manufacturing Execution Systems (MES).
• Delta V & Distributed Control Systems (DCS).
• Laboratory Information Management Systems (LIMS).
• ERP Systems Validation.
• Electronic Document Management Systems (EDMS).
• 21 CFR Part 11 Compliance & Data Integrity.
• Risk Assessment & Failure Mode Effect Analysis (FMEA.