Validation Engineer | 12-Month Fixed Term Contract
Location: Manorhamilton Road, Sligo
Are you a detail-oriented engineer looking to broaden your expertise across a diverse range of validation activities? My client is seeking a proactive Validation Engineer to join their Technical Operations team in Sligo.
Your mission is to ensure that every process, piece of equipment, and software system operates at the highest standard of compliance.
- Program Coordination: Implement and drive the site's Validation Program, ensuring alignment with FDA, European cGMP, and GAMP standards.
- Data Integrity: Guarantee that all computerized systems are qualified and strictly adhere to Data Integrity policies.
- Documentation Lifecycle: Author, maintain, and review Validation Master Plans (VMP), Project Validation Plans, protocols, and final reports to rigorous cGMP standards.
- Cross-Functional Validation: Participate in the validation of site facilities, utilities, and manufacturing processes.
- Change Management: Manage and oversee the validation change control process to maintain a "ready-to-audit" state.
- Safety & Compliance: Champion EHS & E standards, ensuring a safe and compliant working culture.
We are looking for a candidate who balances technical rigor with excellent communication skills.
- Education: A 3rd level degree in a relevant Engineering or Scientific discipline.
- Experience: At least 2 years of hands-on experience within a cGMP-regulated pharmaceutical manufacturing setting.
- Technical Writing: Proven ability to transform complex technical data into clear, concise protocols and reports.
- Precision: A high level of mental concentration and an eagle eye for detail to ensure total regulatory accuracy.
- Agility: A natural problem-solver who can adapt quickly to evolving regulatory requirements.
This is a chance to work on a site that values technical excellence and provides a supportive environment for professional growth. If you are ready to take the next step in your validation career, we want to hear from you.
