LSC have a great contract opportunity for a Process Project Engineer to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Manage projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects
- Maintain contact with the Project Sponsors to ensure engineering solution development remains aligned with the project's business case.
- Responsible, with the Project Manager, for the development and maintenance of the scope, budget and timelines. Adequately resource core team in support of scope and schedule targets.
- Act as a subject matter expert on: equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs and requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation.
- Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Experience as a Capital Projects Team Lead for large capital projects (>$5MM) preferable.
- Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage.
- In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
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!
Apply via this advert or contact Cian Marnane at LSC on 021 4777329 if you have any more questions about this role!
