LSC have a great contract opportunity for a Process Engineer to join a global Biopharmaceutical company in Carlow.
If you have 10 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Lead and execute process engineering activities to support the technical transfer of products to site. This includes but is not limited to: cycle development, Equipment PQ, PPQ’s, Cleaning, PCM, CTU mapping, filter validation, etc.
o Plan, schedule and resource the complete technical transfer programme and then to lead the team to successful completion of the product introduction to regulatory approval and initiation of commercial production.
o Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams to ensure that the process and product requirements are met.
o Providing technical and product oversight to the process, design and project delivery teams and coaching to associate staff within the assigned suite.
o You and your team will be required to Author and review procedures and technical reports required as part of the technical transfer.
o You and your team will be Technical review and approval of Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Process or technical transfer experience on Large Scale Projects
o Leadership experience managing a team to deliver short and long term objectives as part of a project or program.
o Project Management experience / training in use of Project Management tools.
o SME on Equipment within a sterile fill finish environment; e.g. CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels
o Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
To apply, submit your CV via this advert or contact Kathy Gillen at LSC on 021-4777329 if you have anymore questions about this Process Engineer opportunity!