Validation Team Lead

Job Title: Validation Engineer
Contract Type: 12-Month Contract
Location: Galway, Ireland
Employment Type: Full Time

Role Overview

A Validation Engineer is required to execute validation activities in compliance with applicable regulatory requirements and site quality standards. The role supports the Validation Team Lead in delivering the Validation Master Plan, maintaining validation documentation and SOPs, and executing validation activities across processes, cleaning, equipment, analytical instruments, and utilities.

Key Responsibilities

• Develop, execute, and document validation protocols and summary reports for:
• Process validation
• Cleaning validation
• Equipment qualification
• Analytical instrument validation
• Utility system validation
• Ensure all validation activities comply with GMP, regulatory guidelines, and internal quality systems.
• Support technology transfer activities and new product introductions through validation execution.
• Maintain accurate, complete, and audit-ready validation documentation in line with SOPs and regulatory expectations.
• Assist in the review, update, and implementation of validation SOPs under the direction of the Validation Team Lead.
• Ensure validation documentation and records are inspection-ready for internal and external audits.
• Identify and contribute to continuous improvement opportunities within validation systems and processes.
• Support alignment of validation practices with evolving regulatory requirements and industry standards.
• Collaborate with Manufacturing, Quality, Engineering, and Analytical teams to coordinate validation activities.
• Provide technical support during deviations, troubleshooting, and validation-related investigations.

Qualifications & Experience

• Degree in Engineering, Pharmaceutical Science, or a related discipline.
• 2–4 years’ experience in validation within a GMP-regulated environment.
• Experience in process, cleaning, and equipment validation preferred.

Skills & Competencies

• Strong knowledge of GMP and validation principles.
• Solid understanding of validation lifecycle and regulatory requirements.
• Strong documentation, organisation, and attention-to-detail skills.
• Ability to work effectively in cross-functional teams.
• Strong problem-solving and troubleshooting capability.
• Commitment to quality, compliance, and data integrity.
• Ability to manage multiple priorities in a regulated environment.