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.
Skills: C&Q QA QC Validation ASTM E2500 Eudralex