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Details

Senior Validation Engineer


Reference:SMC0036592 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Validation Engineer

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.

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.

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.
• 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