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Angela McCauley
Life Science

+353 87 696 0951
[email protected]
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Details

Senior Validation Engineer


Reference:AMC22531 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Engineer, Validation Engineer

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

Responsibilities:

The successful candidate will be involved in the project from Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation and Product PQ – including filing with regulatory bodies.
Levels of responsibility will vary during this timeframe as outlined below –
Managing the workload and providing coaching for a team of Validation Engineers within the assigned area working on;
  • 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.

Required Experience:
  • 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.

Desirable but not essential;
  • 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.

Apply today or get in touch with Angela McCauley at Life Science Recruitment for more information.