19759-Validation Engineer-Carlow Contractor

This is an 11-month contract initially.

Purpose

The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic, and committed engineers are in the following areas: Sterilisation – Autoclaves, SIP of vessels, Cleaning – Parts Washer and CIP of vessels Isolator (Filling, Sterility & Material Transfer isolators) – HVAC, VHP, E-Beam and Dehydrogenation systems, Controlled Temperature Units (CTU) – Temperature/Humidity Mapping, Filter Validation.

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 the execution of Cycle Development and Performance Qualification activities.

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

• Perform root cause analysis of system failures, and 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, and 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.

Knowledge and experience of the below areas will be considered advantageous

• 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

• Temperature Mapping

• Cleaning Validation

Requirements

• 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 of delivering excellence.