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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Senior Cleaning Validation Engineer


Reference:AMC22966 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Snr Validation Engineer

11 month contract
Senior Validation Engineer - Cleaning
On site Carlow
AMC22966


We are currently hiring for a Senior Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support Cleaning validation on site.

The ideal candidate will have 5+ years of experience in validation of sterile fill finish processes and equipment including extensive cleaning validation experience


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.

Requirements
  • Relevant technical degree
  • 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
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.
  • 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
Desirable
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment
  • Evidence of continuous professional development
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
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

Get in touch with Angela McCauley or apply today