Validation Engineer

Summary:
A Validation Engineer is required for a biopharmaceutical company in Carlow. The successful candidate will support several aspects of Validation predominantly qualification of Controlled Temperature Units (CTU).

Responsibilities:

• 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 on site.
• May be required to perform other duties as assigned.

Qualifications & Experience:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
• 4+ years’ experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting.
• Knowledge of CTU equipment qualification.
• Knowledge of thermal mapping equipment.
• Thermal mapping skills.
• 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.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Sterile Fill-Finish processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications required.
• Equipment Periodic Validation.
• Equipment Validation Lifecycle.
• Project Management Skills/Qualification.
• Filter Validation & Container Closure Validation.
• Autoclave/SIP Sterilisation Validation.
• Dry Heat Sterilisation.
• Isolator Qualification.
• Vial and Syringe Processing Technologies.