• Contract
  • Carlow

Website Asset Recruitment

Asset Recruitment

Ref: 10176

Validation Lead

Description
• The role requires an experienced, energetic, and committed technical lead with broad experience in at least five of these areas below.
• Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.
• Vial and Syringe Filling operations – Glass handling, Tray & Tub handling, Drug Product Filling.
• Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
• Parenteral Product Visual Inspection (Automated Inspection).
• Cleaning Validation in Biotech facility & Cleaning Processes
• Sterilisation Validation – Autoclave & Load Qualification
• Single Use Technologies – SUT
• High Potency and OEB5 products & containment methodologies

Role
• The successful candidate will be involved in the project from Detailed Design, Construction, Site Acceptance Test (SAT) at the earliest, through to the Equipment Performance Qualification, Validation and Product PQ – including filing with regulatory bodies.
• Managing the workload and providing coaching for a team of Validation Engineers;
• Aligning new facility introduction with Validation approach and author and owner for project VMP
• CQV approver for C&Q and developing Validation strategy documents and project plans and procedures
• Acting as Validation Lead for team of site representatives as system owners for PQ/ Validation
• Factory/Site Acceptance Test – Attendance
• Working with the C&Q Lead to ensure consolidated & compliant approach to C&Q and readiness for CQV crossover into Validation/ PQ executions

Duties
• Application of LeanSixSigma and Change Management tools
• Facilitate problem solving & risk assessment (FMEA) projects/meeting.
• Supporting alignment and knowledge exchange with development organizations, other commercial and external manufacturing partners.
• Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).

Experience & Skills
• 5+ years process equipment CQV experience on Large Scale Projects or commercial operations.
• SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Containment Isolators/Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection
• Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
• Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.
• Experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.

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