- Act as validation SME on the equipment within the area assigned. As such you will be leveraging testing from Commissioning and Qualification.
- Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests.
- Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
- Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
- Implementing the requirements as outlined in the site / project Validation Master Plan.
- Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
- 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 suite for qualification / validation up to PQ stage.
- Effective application of Lean Six Sigma and Change Management tools in the Validation group by: Leading by example in achieving results by using industry standard tools and processes ; Facilitate problem solving & risk assessment (FMEA) projects/meeting; Make problems visible and strive for continuous improvement. Serving as a key member during internal audits and external inspections/audits. Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
- Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
Qualifications & Education
- Experienced individual with directly related experience in pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
- Experience in process equipment C&Q/ Validation experience on Large Scale Projects
- SME on Equipment Validation on any of; 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 / ISPE guidelines
- Experience with liaising with other departments – engineering, technical, operations and QA
- 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 a plus.
- Prior 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 etc. and trending, analysing and interpreting complex data
- Warehouse and CTU qualification
- Visual Inspection technologies for Vial & Syringe
- Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
- New facility brown/ green field facility 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.
To apply contact Martin Lynch on 087-344 3581.
Email CVs to email@example.com