Website Asset Recruitment
An exciting new opportunity for an experienced Process Equipment SME to join one of the world’s most advanced biopharma companies operating at the cutting edge of life science technology delivering quality veterinary vaccines and medicines complemented by a diverse range of diagnostic products and genetic tests
The Process Equipment SME will join the senior client project management team on this multi-million-euro greenfield manufacturing facility construction project in Tullamore. Reporting to the manufacturing building project manager, the selected candidate will manage the design and installation of all process equipment.
- Lead design, build, commissioning and qualification of manufacturing facilities and systems of biopharmaceutical therapeutics Be responsible for the full life cycle of the project from concept to completion
- Lead capital and noncapital projects, and process engineering function insight into the equipment, processes, and operations requirements.
- Manage installation / start-up / testing of process systems through OQ completion.
- Interface with cross-functional team to ensure systems’ post-OQ (PQ) readiness
- Providing day to day support and coordination during full cycle of design, build, and C&Q.
- Liaison with manufacturing, engineering, QC and QA functions in other sites to define user’s requirement and transfer knowledge to EPCMV and vendors.
- Establish technical support initiatives for GMP operations in a multi-product cell culture and purification facility.
- Lead cross-functional project teams to ensure specific unit operation requirements are implemented and tested in C&Q deliverables.
- Develop and/or review system lifecycle documents including C&Q documentation.
- Ensure all project stakeholders are informed and consulted on key process activities and decisions
- Act as client representative to ensure that critical design deliverables are provided and provide direction & oversee design progression by Engineering Design Team
- Ensure all relevant engineering standards, procedures and best practices are followed
- Ensure Design Risk Assessments and HAZOPs are performed
- Ten+ years proven engineering experience – at least 8 years within pharmaceutical, biotech, life sciences industries or EPCMV firm is required
- Bachelor degree in Chemical or Process Engineering.
- Chartered Engineer
- Strong project management skills with good communications skills
- Good time management skills and ability to work in fast-paced environment
- Hands-on experience in process equipment for the biotech industry
- Familiar with pertinent industry safety codes and policies per national and international regulatory agencies ( FDA, EMA and HPRA)