Validation SME

We are looking for an experienced Validation Subject Matter Expert (SME) with strong knowledge of pharmaceutical and life sciences validation processes, regulatory compliance, and quality systems. The candidate will provide technical expertise and leadership for validation activities across manufacturing, laboratory, utilities, and computerized systems.

Key Responsibilities

• Lead and provide SME support for validation and qualification activities.
• Develop and review Validation Master Plans (VMPs).
• Manage equipment, process, cleaning, and facility validation.
• Oversee IQ, OQ, PQ protocols and reports.
• Provide expertise in Computer System Validation (CSV) and GAMP 5.
• Ensure compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and applicable regulatory guidelines.
• Support process validation and continued process verification.
• Review risk assessments, deviation investigations, CAPA, and change controls.
• Support internal audits, external audits, and regulatory inspections.
• Collaborate with QA, QC, Engineering, Manufacturing, and IT teams.
• Mentor validation engineers and ensure timely execution of validation projects.

Required Skills

• Strong experience in pharmaceutical or biotechnology validation.
• Knowledge of FDA, EMA, WHO, and GMP regulations.
• Experience with equipment, process, cleaning, and utility validation.
• Knowledge of CSV, GAMP 5, and data integrity.
• Strong documentation and technical review skills.
• Experience in audit and inspection support.
• Excellent communication and stakeholder management skills.

Preferred Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or Engineering.
• Experience working in regulated pharmaceutical or biotechnology environments.
• Exposure to global regulatory requirements and validation lifecycle management