Lead Senior Computerized System Validation CSV Consultant

Job Summary :

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 GMPregulated pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in Manufacturing Systems (MES) Delta V and laboratory system validation with strong leadership and project management skills.

Responsibilities :

• Develop and manage CSV strategy and 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 riskbased 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 crossfunctional 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 crossfunctional teams on CSV best practices and compliance requirements.
• Manage project timelines budgets and resources to ensure timely delivery of validation activities.

Requirements :

Preferred Qualifications & Certifications :

Technical Expertise :

Key Skills

IT Experience,Business Continuity Planning,System Design,Agile,Military Experience,Waterfall,Business requirements,Jira,Sharepoint,SDLC,Data Analysis Skills,Groovy

Employment Type : Full Time

Experience : years

Vacancy : 1