Validation Engineer

Summary:
Our client is a biopharmaceutical company based in Carlow looking for a Senior Validation Engineer to join its team for a significant expansion project transitioning the new facility from construction & project phase to a commercialisation of fully operational facility delivering life-saving products to patients.

Responsibilities:

• 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.
• Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area.
• Implementing the requirements as outlined in the site & project Validation Master Plan(s).
• Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
• Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
• Supporting regulatory submissions as required.
• Owning Change Management process for Equipment introduction within the assigned area for qualification / validation up to PQ stage.
• Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

Qualifications & Experience:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences, Computer Sciences or applied Technical / Engineering qualification.
• Minimum of 6 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
• 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.
• 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.
• 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.