Validation Engineer New

Validation Engineer

Summary

The Validation Engineer is responsible for owning and supporting validation activities within a regulated Medical Device manufacturing environment. The role focuses on ensuring compliant qualification and validation of processes, equipment, facilities, utilities, software, and computer systems while maintaining adherence to GMP and regulatory requirements.

• Own and support validation activities within a Medical Device regulated environment.
• Execute and support Process, Equipment, Facility, Utility, Software, and Computer System Validation activities as assigned.
• Generate Validation Plans, Protocols, Reports, and associated documentation to support validation projects.
• Investigate and resolve issues encountered during validation and qualification activities.
• Ensure a consistent validation and qualification approach across systems, equipment, and projects.
• Provide technical guidance and support for the preparation and execution of validation activities.
• Maintain current knowledge of GMP requirements and regulatory expectations to support site compliance.
• Manage and maintain validation systems, including the completion of periodic reviews.
• Participate in change control activities relating to manufacturing processes, equipment, facilities, utilities, software, and computer systems.
• Support ongoing compliance with quality standards and industry regulatory requirements.
• Ensure compliance with all Health & Safety legislation, policies, and procedures.
• Complete validation activities accurately and within agreed timelines.

• QQI Level 7 Degree in Science, Electronics, Mechanical Engineering, Industrial Engineering, or a related discipline.
• Experience working within a Medical Device Manufacturing and/or Pharmaceutical environment.
• Minimum of 1 year of Quality Assurance and/or Regulatory Affairs experience.
• Experience supporting or executing Process, Equipment, Facility, Utility, Software, and Computer System Validation activities.
• Knowledge of statistical analysis tools, Design of Experiments (DOE), and DMAIC methodologies.
• Experience with the GAMP 5 validation approach is advantageous but not essential.
• Strong technical competency with the ability to interpret and apply validation principles.
• Sound understanding and practical application of structured problem-solving techniques.
• Proficiency in Microsoft Word, PowerPoint, and Excel.
• Ability to respond effectively to inquiries from internal stakeholders and regulatory agencies.
• Strong technical writing skills, including the preparation of SOPs, training materials, validation documentation, and regulatory responses.

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