Validation Engineer

What you will do:

Bring energy, knowledge, innovation to carry out the following:

• Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process. 

• Design/Author/Review/Approve/Execute Execution/development of change controls. 

• Resolving technical issues encountered during study execution. 

• Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities. 

• Technical input into quality notification by authoring/reviewing/approving investigations. 

• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. 

• Support continuous improvement through Lean Six Sigma methodologies. 

• Serve as validation representative for cross functional projects and represent the validation team at global technical forums 

• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. 

• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance 

• Supporting regulatory audits and submissions as required. 

• Work collaboratively to drive a safe and compliant culture in Carlow. 

• May be required to perform other duties as assigned. 

What skills you will need: 

In order to excel in this role, you will more than likely have:

• Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.
• Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills: 

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence. 

• Exception / Deviation Management and Change Control. 

• Demonstratable experience of leading technical related projects. 

• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable 

• Evidence of continuous professional development is desirable. 

• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. 

• Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate. 

• Report, standards, policy writing skills required. 

• Equipment and process validation. 

• Sterile Fill-Finish processes and equipment. 

• Proficiency in Microsoft Office and job-related computer applications

• Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. 

Knowledge and experience of the below areas will be considered advantageous. 

• Filter Validation
• CCI qualification
• Shipping Qualification

• Equipment Periodic Validation 

• Equipment Validation Lifecycle 

• Project Management Skills/Qualification 

• Autoclave/SIP Sterilisation Validation 

• Dry Heat Sterilisation 

• Isolator VHP/HVAC Qualification 

• Controlled Temperature Units/Equipment Qualification 
• Vial and Syringe Processing Technologies