Medical Device Design jobs in Limerick, County Limerick

Job Title: Validation Engineer

Join Ellab on our exciting growth journey! We are seeking Validation Engineers for a client site in the Limerick area.

About Ellab

Ellab is a complete solutions provider covering validation services, calibration services, monitoring, and temperature mapping systems along with a comprehensive Instrumentation Product portfolio. With over 100 employees in Ireland and offices in Cavan and Cork, our specialist teams work with over 250 clients in Ireland, and we’re trusted partners to the world's largest pharmaceutical companies.

Ellab Ireland Validation Engineers work across the Pharmaceutical and Biotech sectors and with the contractors and manufacturers allied to these industries.

Role Overview

The successful candidate is responsible for ensuring that equipment, systems, and processes used in regulated manufacturing environments are properly designed, tested, and maintained in a validated state in line with GMP and regulatory requirements.

The role involves planning, writing, and executing validation documentation such as validation plans, protocols (IQ/OQ/PQ), and reports. It includes supporting qualification of new and existing equipment, utilities, and/or computer systems, ensuring they consistently perform as intended.

Overall, the role focuses on ensuring product quality, patient safety, and regulatory compliance through robust validation practices and lifecycle management of GMP systems.

Key Responsibilities

• Support the development and execution of CTU mapping activities for manufacturing equipment across upstream and downstream processes.
• Assist in identifying worst-case locations, product contact surfaces and sampling points to support cleaning validation strategies.
• Develop and execute cleaning validation protocols, including Cleaning Cycle Development and Performance Qualification (PQ) studies.
• Coordinate and perform cleaning validation studies, ensuring CTU mapping requirements are incorporated into study design and execution.
• Perform accurate and consistent rinse and swab sampling at designated CTU and worst-case locations.
• Assess cleaning issues encountered during study runs and support investigations as required.
• Generate technical documentation including cleaning evaluations, calculations, protocols, reports, deviations, root cause analyses and impact assessments.
• Ensure activities are executed in compliance with GMP, FDA and EU regulatory requirements.
• Maintain and update validation lifecycle documentation, including CTU mapping records and cleaning validation documentation.
• Collaborate with Manufacturing, Quality, Engineering and Validation teams to support cleaning validation and equipment qualification activities.
• Provide recommendations for improvements to cleaning processes, equipment cleanability and manufacturing operations.
• Support internal and external audits and regulatory inspections.

Qualifications & Experience

• Bachelor's Degree in Engineering, Science, Biotechnology, Chemistry, Pharmaceutical Science or a related discipline.
• Minimum 2-5 years' experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
• Experience supporting cleaning validation activities, including protocol execution, sampling and report generation.
• Experience with CTU mapping, worst-case assessment, and identification of sampling locations is highly desirable.
• Knowledge of cleaning validation lifecycle requirements and associated regulatory expectations.
• Familiarity with GMP, FDA, EMA and EU Annex 15 requirements.
• Experience performing rinse and swab sampling and interpreting analytical results.
• Experience authoring and reviewing validation documentation, including protocols, reports, deviations, investigations and change controls.
• Strong technical writing, problem-solving and root cause investigation skills.
• Ability to collaborate effectively with cross-functional teams including Manufacturing, Quality, Engineering and Technical Services.
• Proficiency in Microsoft Office applications.
• Excellent communication and organisational skills.

Soft Skills

• Strong attention to detail
• Excellent communication skills
• Problem-solving and analytical thinking
• Ability to work cross-functionally
• Time management and organisation
• Proactive and adaptable mindset

What We Offer

• The opportunity to join a dynamic and rapidly growing company on a steep growth curve.
• A supportive and collaborative work environment where you can make a real impact.
• Market Leading salary and benefits package.
• Opportunities for professional development and growth.
• 21 Days Annual Leave
• Company Pension – Employer matches 5%
• Employee Assistance Programme.
• Income Protection Benefit.
• Death in Service Benefit.

Join Us:

If you're passionate about making a difference, both in your career and in the lives of others, we invite you to join our team. Apply now and become part of our journey. If you have any questions about the position, please reach out to our HR Team at hr-irl@ellab.com

Job Types: Full-time, Permanent

Pay: €45,000.00-€55,000.00 per year

Work Location: In person