Job ref: 11442
Join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients.
The role supports 4 technical areas. The successful candidate must have experience in 1+ of the following:
Sterilisation – autoclaves, SIP of vessels
Cleaning – Parts Washer, CIP of vessels
Vial and Syringe filling operations
Vial and Syringe Sterility operations
Each role will be involved in the project from vendor FAT at the earliest, through to the performance qualification (PQ).
Engage in early project stages; give input to design, attend FAT and design reviews to represent client validation interests, oversee equipment C&Q within assigned areas
Act as validation SME on the equipment within the assigned area – leverage testing from commissioning and qualification
Provide technical and validation oversight to process, design and project delivery teams
Implement requirements as outlined in the project validation master plan
Coordinate engineering sub-teams during execution of Cycle Development and Validation activities
Author and review SOP and technical reports including PQ protocols
Technical review and approval of commissioning protocols, qualifications protocols and validation protocols executed by vendors
Own change management process for equipment introduction within the assigned suite for qualification / validation up to PQ stage
Qualifications, Skills & Experience:
Bachelor’s degree in Engineering, Science or other Technical discipline
5+ years directly related experience in the pharma or biotech industry
3+ years process equipment C&Q / Validation experience on Large Scale Projects
SME on equipment validation on any of the following – CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels
Working knowledge of ASTM E2500 / Eudralex / FDA guidelines
Experience with sterile processing and sterilisation technologies
Experience with cleaning and process validation, technology transfer, regulatory filing and commercial drug product manufacturing of biologics is an advantage
Previous experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection
SIP and CIP subject matter extensive experience
Autoclave qualification and sterilisation loads cycle development experience
Use of temperature mapping equipment such as Lives/Kaye
Visual inspection technologies for Vial and Syringe
Vial and syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
New facility brown / greenfield experience
Small equipment qualification and validation: FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.
Project Management experience / training in use of Project Management tools.