Process Simulation Technical Engineer Position
We are seeking a highly skilled Process Simulation Technical Engineer to support our operations in Carlow. The successful candidate will be responsible for providing process, technical, and validation support to ensure efficient Process Simulation development and execution.
This role requires the ability to design, author, review, approve, and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
Key Responsibilities:
* Develop and implement process simulation qualification/validation documentation and studies in line with standard approval processes.
* Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
* Support continuous improvement through Lean Six Sigma methodologies.
* Lead and participate in projects, system failure investigations, and investigation reports.
* Implement subsequent corrective action through change management systems.
* Represent technical operations Carlow at global technical forums in relation to process simulations.
* Participate in 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 day-to-day activities.
Requirements:
* Bachelor's Degree or higher preferred, ideally in a Science, Engineering, or other Technical Discipline.
* 3-5 years of experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.
* Demonstrated ability to coach and lead change.
* Strong knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environments.
* Lean Six Sigma Methodology experience desired.