Join a dynamic biotech team as a Process Simulation Technical Specialist. We are seeking an experienced professional to support process development, technical and validation activities for our sterile manufacturing operations in Carlow.
* Serve as key technical support for manufacturing and new product introduction.
* Design, author, review, approve and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
* Provide technical input into quality notifications by authoring, reviewing and approving process simulation related investigations.
* Design, author, review, approve and execute process simulation qualification/validation documentation and studies in line with the standard approval process.
* Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
* Support continuous improvement through Lean Six Sigma methodologies.
* Lead and actively participate in projects, system failure investigations and investigation reports.
* Execute/develop change controls to support the Process Simulation process.
* Contribute 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 whys etc.
* Implement subsequent corrective action through the change management system.
* Serve as technical engineering representative for internal technical group discussions and represent technical operations at global technical forums in relation to process simulations.
* Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
* Drive compliance of Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
* Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
* Work collaboratively to drive a safe and compliant culture.
* May be required to perform other duties as assigned.
We are looking for a highly skilled professional with a strong background in process simulations, technical support and validation. The ideal candidate will have a bachelor's degree or higher in a science, engineering or other technical discipline, with 3-5 years experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution. Demonstrated ability to coach and lead change is essential. Strong knowledge of sterile manufacturing processes with a focus on delivery and results within highly regulated controlled environments is desirable. Lean Six Sigma Methodology experience is also desired.