Validation Engineer

Validation Engineer

Chanelle Pharma

Loughrea, Ireland

Basic Role Summary:

To execute validation activities in compliance with regulatory requirements and company standards. The Validation Engineer supports the Validation Team Lead in implementing the Validation Master Plan, maintaining validation-related SOPs, and performing validation for processes, cleaning, equipment, analytical instruments, and utilities.

As our Validation Engineer, your key responsibilities will be as follows:

• Develop, execute, and document validation protocols and reports for process, 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 accordance with SOPs and regulatory requirements;
• Assist in updating and implementing validation-related SOPs under the guidance of the Validation Team Lead;
• Ensure validation records are audit-ready and support internal and external inspections;
• Identify opportunities to improve validation processes and enhance efficiency;
• Contribute to initiatives that align validation practices with evolving regulatory expectations;
• Work closely 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 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 functions;
• Solid knowledge of validation methodologies and regulatory requirements;
• Ensures accuracy and completeness in validation documentation;
• Ability to troubleshoot and resolve validation-related issues;
• Works effectively with cross-functional teams;
• Commitment to maintaining high standards of quality and regulatory compliance.