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Senior Validation Engineer

Asset Recruitment
Carlow, Country: Ireland
Job Type:
Job Description
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

Desirable experience:
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.
Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Asset Recruitment
Company size: 1-49
Contact: NA