Senior CSV Engineer, Digital Solutions

23 month FTC hybrid job based in Carrigtwohill, Cork

Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at several sites. Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.  

Position  

Requirements  

• Will work with the Operations Engineering and AO Digital Systems Teams, responsible for validation related activities, including, but not limited to the following:  

• Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.   

• Being Subject Matter Expert (SME) for more than 1 validation specialty for development of Corporate Procedures and Work Instructions.  

• Participating in Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.  

• Representing validation at both internal and external audits.    

• Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.  

• Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.  

• Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.  

• Reviewing and approving of Validation/Qualification Documentation.  

• Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.  

• Mentoring for Graduate Validation Engineers.  

QUALIFICATION  

KNOWLEDGE  

SKILLS   

• Bachelor of Science, Engineering or related subject and some experience in validation a bonus

• Excellent communication skills and attention to detail.  

• Have a good understanding of engineering and machine tool fundamentals.  

• High level of PC skills.   

• Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.  

• Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.   

• Must be willing to work as part of a multi-site team, be able to travel as part of the job   

• Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.   

• Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.  

• Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs.   

• Lean Six Sigma training a distinct advantage.