Validation Engineer - 12 Month Contract
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.
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.
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For a confidential discussion and more information on the role, please contact Davin Ferguson
davin.ferguson@collinsmcnicholas.ie
071 9140251
