A C&Q Engineer is required by a top 10 Pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution. The facility takes in raw chemicals and ships finished medicines to end users. This site has grown from an API site, to a strategically important campus that supports critical stages of the company's drug lifecycle. Come join this people focussed, innovative, flexible, fast paced team as they work in this critical role.
Excellent opportunity for a C&Q SME:
- Work with Process Design Managers in the development of Regulatory Design Basis and C&Q Execution Strategy during Concept and Basis of Design phases of projects.
- Support project teams in assessing project level staffing needs to ensure that appropriate C&Q staffing, expertise and leadership (both with internal and external resources) exists to successfully execute projects.
- Facilitate GMP design reviews, design qualification and collaborate on the development of Project Validation Master Plans and execution of Product Quality Risk Assessments
- Provide direct project support for strategic and at risk projects to ensure successful execution of the C&Q strategy.
- Participate in project assessments for active projects to identify opportunities for improvement and confirm readiness for project to progress through the stagegate process.
- Acts as a subject matter expert on: regulatory compliance in facility and equipment design and qualification; 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, Construction QA/QC, Turnover Pack compilation, Document Mgt. Systems, FAT/SAT and C&Q protocol development
The C&Q Engineer requires:
- Extensive C&Q experience, including a C&Q leadership role on a significant large capital project in the Pharmaceutical / Biotech Industry
- Experience in Drug Substance, Drug Product, and clean and black utility systems
- Experience staffing and managing contract personnel on a project team basis
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!
Call Siobhan Cummins in LSC on 021 4777 329 to discuss this new Procurement Assistant role in more detail or apply directly via this advert