LSC have a great contract opportunity for a Process Engineer to join a global Biopharmaceutical company in Carlow.
If you have 2 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 Execute process engineering activities to support the technical transfer of products to site. This includes but is not limited to: engineering studies, equipment tuning, development batches, single use component fit checks, process simulations, PPQ’s, etc.
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 Provide technical and product guidance to the process, design and project delivery teams.
o Author and review procedures and technical reports as required as part of the technical transfer.
o Review and approve Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
o Lead and support component criticality assessments for the process and create control strategies.
o Execute activities as part of the Change Management process for the product introduction.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Process or technical transfer experience.
o Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines
o Experience with liaising with other departments – engineering, technical, operations, supply chain, QA and Regulatory Affairs.
o Experience with sterile processing and sterilisation technologies
o Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
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 Martin Taggart at LSC on 021-4777329 if you have anymore questions about this Process Engineer opportunity!