We’re currently recruiting for an exciting opportunity with an award winning medical device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
• Competent in validation requirements on new processes, equipment introductions &
• Responsible for performing process validation studies by following approved standard
operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other
• 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.
Education & 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).
• Degree qualified in a relevant Engineering / Science discipline, with relevant
• Experience in Statistical analysis is essential.
• Experience in regulated industry, FDA, ISO, etc.
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480