Validation Lead

EFOR; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

EFOR is seeking a Validation Lead to oversee validation activities for equipment, utilities, processes and computerized systems ensuring compliance with FDA, EMA and cGMP standards. You will plan, coordinate and execute validation projects, manage documentation and maintain validated status.

The role requires strong leadership, project management and communication skills, plus experience with IQ/OQ/PQ, risk assessments, and close collaboration with engineering, QA and IT.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or Pharmacy; Master’s preferred.
• 7+ years of validation experience in regulated pharma/biotech/medical device.
• Strong knowledge of FDA/EMA/ICH Q7–Q10 and GAMP 5.
• Experience with IQ/OQ/PQ and validation documentation.
• Excellent communication, leadership, and problem-solving skills.

Responsibilities

• Lead validation projects for manufacturing processes, equipment, cleaning, utilities, and computer systems.
• Develop and revise validation master plans, protocols, and reports.
• Ensure activities comply with quality systems and regulatory requirements.
• Coordinate execution of protocols and timely documentation.
• Review and approve validation docs, change controls, risk assessments, SOPs.
• Maintain master schedule and track project status.
• Mentor junior staff and provide technical guidance.
• Serve as primary contact for regulatory inspections on validation.
• Support deviation investigations and CAPA related to validation.
• Collaborate with engineering, QA, production, IT to align validation and operations.

Skills

Project management

Leadership

Communication skills

Analytical thinking

Problem-solving

Education

Bachelor’s degree in Engineering, Life Sciences, Pharmacy

Master’s degree preferred

Job description

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.