Job Summary
The Validation Lead oversees all validation activities related to equipment, utilities, processes, and computerized systems to ensure compliance with regulatory requirements (such as FDA, EMA, and cGMP standards). This role is responsible for planning, coordinating, and executing validation projects, managing documentation, and ensuring validated status is properly maintained. The Validation Lead acts as a subject matter expert and provides guidance to validation team members and cross-functional stakeholders.
Key Responsibilities
- Lead and manage validation projects for manufacturing processes, equipment, cleaning, utilities, and computer systems.
- Develop and revise validation master plans, protocols (IQ/OQ/PQ), and reports.
- Ensure validation activities comply with internal quality systems and applicable regulatory requirements.
- Coordinate execution of validation protocols and ensure timely completion of related documentation.
- Review and approve validation protocols, reports, change controls, risk assessments, and standard operating procedures (SOPs).
- Maintain validation master schedule and track status of ongoing projects.
- Train and mentor junior validation staff and provide technical expertise to project teams.
- Serve as the primary point of contact for regulatory inspections in matters related to validation.
- Support deviation investigations, CAPA (Corrective and Preventive Actions), and root cause analyses related to validation issues.
- Collaborate with engineering, quality, production, IT, and other departments to ensure alignment between validation and operational requirements.
Qualifications & Skills
- Bachelor’s degree in Engineering, Life Sciences, Pharmacy, or a related field (Master’s preferred).
- Minimum of 7 years’ experience in validation within a regulated pharmaceutical, biotechnology, or medical device environment.
- Strong knowledge of regulatory standards related to validation (e.g., FDA, EMA, ICH Q7/Q8/Q9/Q10, GAMP 5).
- Experience with equipment, process, cleaning, and computer system validation.
- Excellent project management and leadership skills.
- Strong analytical and problem-solving abilities.
- Excellent written and verbal communication skills.
- Experience with risk assessment methodologies (e.g., FMEA, HACCP) is a plus.
