Senior Validation Engineer
12 month contract
On site Carlow
AMC22531
Start date ASAP

I am looking for an experienced Equipment Validation Engineer to support the transition of a new biomanufacturing facility from project phase to a fully operational manufacturing facility.

This role would be suitable for a CQV/lead Engineer with 6+ years experience in Vial and Syringe Filling operations. The scope of this role will involve Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation and Product PQ – including filing with regulatory bodies.

The role will require the leadership of an experienced, energetic, and committed Senior/ Lead Engineering (CQV/ Technical Engineer) with broad experience in Vial and Syringe Filling operations and the below key areas.

The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience.

• Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems.
• Cleaning Validation in Biotech facility & Cleaning Processes
• Sterilisation – Autoclave & Load Qualification
• Single Use Technologies – SUT and SU components/ manifolds
• Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation
• Ancillary Equipment for Bio-processing – Tube Welders/ Sealers/ Filter Integrity / Glove Integrity Testing
• Formulation processing using DeltaV including Transfer Panel and Utility Qualification.
• Parenteral Product Visual Inspection (Automated Inspection).
• High Potency and ICH Q5 products & containment methodologies

• Aligning new facility introduction with Validation approach across Carlow site and review and approval of project VMP
• CQV approver for C&Q documents and input to Validation strategy documents and project plans and procedures
• Acting as Validation SME within a team of site representatives as system owner for PQ/ Validation
• Site Acceptance Test – Attendance, hands-on support and C&Q Oversight for assigned process equipment.
• Working with the C&Q Lead to ensure consolidated & compliant approach to C&Q and readiness for CQV crossover into right-first-time Validation/ PQ executions.
• Commissioning & Qualification – Hands-on support & Oversight for assigned process equipment.
• Cycle Development – Execution of Cycle Development pre and post OQ phases for assigned process equipment.
• Performance Qualification – Responsibility for / Execution of Performance Qualification testing for assigned process equipment.
• Liaising with Tech Transfer team to ensure product requirements are met.
• Ownership of updates to Technical SOPs related to Validation and assigned process systems.
• Managing site change controls as part of QMS implementation of the new facility as required.
• Ensuring that PQ and Validation are aligned with the regulatory & market requirements for filing the new facility and product licensure at the close out of the project.

• Minimum 6 years C&Q/ QA/ QC/ Validation experience in highly regulated industry.
• Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.
• Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach
• SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide 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.
• Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.

• Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
• Clean Utilities and HVAC system Qualification.
• New facility brown/ green field facility introduction experience, or training & developing a team within a commercial manufacturing environment.
• Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.
• Experience with sterile processing and sterilisation technologies is advantageous.
• Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
• Project Management experience / training in use of Project Management tools and software tools.
• Use of Delta V and associated new Phase development and Qualification works.