Validation Engineer (12-Month FTC)
- Location: Galway
- 12-Month Fixed-Term Contract
- Pharmaceutical / GMP Regulated
Our client is seeking a dedicated and detail-oriented Validation Engineer to join their team in Galway for a 12-month fixed-term contract. In this role, you will execute vital validation activities in strict compliance with regulatory requirements and company standards.
Supporting the Validation Team Lead, you will play a key role in implementing the Validation Master Plan, maintaining validation-related SOPs, and ensuring the seamless validation of processes, cleaning, equipment, analytical instruments, and utilities.
Key Responsibilities
As a Validation Engineer, your core duties will include:
- Develop, execute, and document comprehensive validation protocols and reports for processes, cleaning, equipment, analytical instruments, and utilities.
- Ensure all validation activities consistently comply with GMP, regulatory guidelines, and internal procedures.
- Support technology transfers and new product introductions through targeted validation activities.
- Maintain accurate, thorough, and complete validation documentation in strict accordance with SOPs.
- Assist in updating and implementing validation-related SOPs under the guidance of the Validation Team Lead.
- Ensure all validation records are continuously audit-ready to support both internal and external inspections.
- Identify opportunities to optimize validation processes, enhance efficiency, and align practices with evolving regulatory expectations.
- Work closely with manufacturing, quality, engineering, and analytical teams to smoothly coordinate validation activities.
- Provide technical support and expertise during investigations and troubleshooting related to validation.
Qualifications & Experience
- A Degree in Engineering, Pharmaceutical Science, or a closely related discipline.
- 2+ years of hands-on validation experience within a GMP-regulated environment.
- Prior experience in process, cleaning, and equipment validation is highly preferred.
Skills & Competencies
- Deep understanding of GMP and core validation principles and methodologies.
- Excellent documentation, written communication, and organizational skills.
- Strong troubleshooting capabilities with a knack for resolving validation-related issues.
- A collaborative mindset with the ability to work effectively across various functional teams.
- An uncompromising eye for accuracy and completeness in technical documentation.
