LSC have an exciting contract opportunity for a Process Engineer III to join a leading Biotech company based in Dublin.
If you have minimum of 5 years’ (for MSc) or 7 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – 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 Support the design, construction and qualification of upstream & downstream equipment at MSD Biotech Dublin through to technology transfer and commercialization.
o Support establishment of the commercial process and routine manufacturing by:
Supporting experimental design, execution, data analysis and interpretation.
Interpreting trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC) multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
Supporting deviation management.
Supporting change control prioritization and implementation.
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o With a Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry (or PhD without industry experience), the successful candidate will also ideally have a proven track record in delivering excellence.
o Experience with upstream cell culture and/or downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.
o Technical operations experience in the drug substance manufacture of biological molecules at commercial-scale.
o Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing
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!