The Client:
Our client, one of the leading MedTech companies in Ireland, is looking for a highly motivated and experienced Validation Engineer(Industrial) to work in Ireland.
What You’ll Love:
- This role is part of a long-term project, so this is an excellent opportunity to work for one of the leading MedTech companies in Ireland on a Permanent basis.
- The role offers a Competitive Salary, and Hybrid working option is available.
What you are expected to have:
- Bachelor’s or Master’s degree in Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
- 5+ years of experience in manufacturing equipment validation, qualification, or a related engineering role within the medical device or pharmaceutical industry.
- At least 2 years of experience in project management, leading cross-functional teams and driving complex projects to completion in a regulated environment.
- Familiarity with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and cGMP.
- Expertise in validation practices (IQ/OQ/PQ) and associated documentation.
- Hands-on experience with manufacturing systems and equipment used in medical device production.
- Strong project management skills, including the ability to create project timelines, track progress, and mitigate risks. PMP certification is a plus.
- Strong analytical and problem-solving skills, including root cause analysis and CAPA management.
- Ability to work collaboratively in a cross-functional team environment.
- Excellent communication skills, both written and verbal, with the ability to prepare detailed reports and present findings to management.
- Knowledge of industry-specific software, such as LIMS (Laboratory Information Management Systems), ERP (Enterprise Resource Planning), or Veeva Vault, is a plus.
- Familiarity with risk management principles (e.g., FMEA, Risk Assessment) and their application in equipment validation.
What you will do:
- Plan, execute, and manage validation protocols for manufacturing equipment, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure compliance with regulatory standards (FDA, ISO 13485, etc.).
- Lead the qualification of new and existing manufacturing equipment to ensure proper installation, performance, and consistent functionality.
- Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant standards throughout validation processes.
- Provide technical expertise on equipment, ensuring that systems and tools meet necessary specifications, performance criteria, and operational requirements.
- Lead root cause analysis and troubleshooting efforts when equipment issues arise during validation, identifying corrective and preventive actions (CAPA).
- Develop and review validation protocols, reports, and SOPs (Standard Operating Procedures) to ensure all activities are properly documented and compliant with regulatory requirements.
- Ensure the traceability and audit readiness of all validation activities, supporting internal audits and regulatory inspections.
- Support the creation and review of regulatory filings and submissions as required.
- Ensure proper documentation practices, maintaining the highest standards for data integrity and quality assurance throughout the validation process.
- Actively participate in continuous improvement efforts within the manufacturing area to optimise equipment performance, reduce waste, and enhance operational efficiency.
- Provide training and mentorship to junior engineers or technicians, guiding them through validation protocols, equipment troubleshooting, and best practices.
- Contribute to lessons learned meetings and share insights to improve future validation processes.
- Lead and manage validation projects from conception through to completion, ensuring all aspects of the project adhere to defined timelines, budgets, and quality standards.
- Develop project timelines and schedules, ensuring all milestones are met and delivering the required project updates to senior management and stakeholders.
- Coordinate cross-functional teams, including Engineering, Quality Assurance, Manufacturing, Regulatory Affairs, and Suppliers, to ensure the success of validation projects.
- Conduct risk assessments for validation activities and ensure mitigation plans are in place.
- Track and report on the progress of validation projects and proactively address any potential delays or risks to project timelines.
- Prepare and maintain validation documentation and ensure compliance with company standards, including change control documentation, project status reports, and validation summaries.
You are good to apply if you are:
- Irish or EU or British Citizen, or holding a Stamp 4 or Stamp 1G permit.
- Residing in the specified job location currently
Why Should You Apply?
Aside from a highly competitive day rate/salary, this role will provide a great balance of support and challenge for someone who wants to take the next step in their career.
Interested? Apply here:
If you feel you’ve got the right skills and experience, we would absolutely love to hear from you!
Fill out the form alongside and do not forget to attach your CV.