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Details

Validation Leader


Reference:SMC035153 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed

We’re currently recruiting for an exciting opportunity with an award winning Medical Device organization based in Cork. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do. The primary purpose of this job is to support major Manufacturing Engineering Projects.The position is part of a team within the Engineering department that contributes to the overall business metrics. This position will provide project leadership on continuous improvement, and risk mitigation initiatives and will also include liaison with outside suppliers and other sites to ensure all goals and targets of the manufacturing process are achieved.

Duties

• Competent in validation requirements on new processes, equipment introductions & process changes.
• Responsible for performing process validation studies by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
• Process Validation for process creation
• Process Validation for the transfer of processes within the facility.
• Defines the requirements for Process Validation studies in alignment with approved SOPs.
• Executes test plans according to approved procedures, performs sampling, tabulates test results, and organizes data packages.
• Compiles and analyses validation data, prepares reports and makes recommendations for changes and/or improvements.
• May also investigate and trouble-shoot problems which occur, and determine solutions.
• Coordinates and executes validation change control and preparation of draft protocols, reports and data tables.
• Maintains and archives all documentation pertaining to validation.
• Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
• As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.
• Independently applies validation principles to work assignments, reviews and approves documents and resolves problems.
• Coordinates assigned projects and represents department on project teams.
• Resolves validation issues of moderate scope with limited direct supervision.

Qualifications & Experience

• Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
• Proficient in current Good Manufacturing Practices (GMPs).
• Full knowledge of industry practices.
• Strong verbal, written, and interpersonal communication skills are required.
• Investigation and report writing skills.
• Proficient in Microsoft Office applications.
• Degree qualified in a relevant Engineering / Science discipline, with 5+ years relevant experience.
• Experience in Statistical analysis is essential.
• Experience in regulated industry, FDA, ISO, etc.
• Demonstrated leadership skills and the ability to make effective decisions


If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480