Job Title: Validation Engineer

Location: Galway

Role Summary:
The Validation Engineer is responsible for executing validation activities in compliance with regulatory requirements and industry standards. This role supports the validation function by implementing validation programs, maintaining validation documentation, and performing validation for processes, cleaning, equipment, analytical instruments, and utilities.

Key Responsibilities:

• Develop, execute, and document validation protocols and reports for processes, cleaning, equipment, analytical instruments, and utilities.
• Ensure validation activities comply with GMP, regulatory guidelines, and internal procedures.
• Support technology transfers and new product introductions through validation activities.
• Maintain accurate and complete validation documentation in line with SOPs and regulatory expectations.
• Assist in updating and implementing validation-related SOPs.
• Ensure validation records are audit-ready and support internal and external inspections.
• Identify opportunities to improve validation processes and enhance efficiency.
• Contribute to initiatives aligning validation practices with evolving regulatory requirements.
• Collaborate with manufacturing, quality, engineering, and analytical teams to coordinate validation activities.
• Provide technical support during troubleshooting and investigations related to validation.

Qualifications and Experience:

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

Skills and Competencies:

• Strong understanding of GMP and validation principles.
• Excellent documentation and organizational skills.
• Ability to work collaboratively across multiple functions.
• Solid knowledge of validation methodologies and regulatory requirements.
• Ensures accuracy and completeness in validation documentation.
• Ability to troubleshoot and resolve validation-related issues.
• Commitment to maintaining high standards of quality and regulatory compliance.