Galway, 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 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.
- 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.
- 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.
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For a confidential discussion and more information on the role, please contact Davin Ferguson
davin.ferguson@collinsmcnicholas.ie
071 9140251
