Job Opportunity for Process Simulation Technical Expert
We are seeking an experienced technical professional to fill a key role in our manufacturing operations.
* Serve as technical support for manufacturing and new product introduction by designing, authorizing, reviewing, approving and executing process simulations studies.
* Provide technical input into quality notifications by authorizing, reviewing and approving process simulation-related investigations.
* Design and execute process simulation qualification/validation documentation and studies in line with the standard approval process.
* Perform data analysis and make informed decisions/recommendations based on data analysis results.
* Support continuous improvement through Lean Six Sigma methodologies.
* Participate in projects, system failure investigations, and investigation reports.
* Execute/develop change controls to support the Process Simulation process.
* Contribute to Kaizen events as necessary.
* Perform root cause analysis of system failures and substandard performance using standard tools and methods.
* Implement subsequent corrective actions through the change management system.
* Serve as a technical engineering representative for internal technical group discussions and represent technical operations at global technical forums.
* 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 day-to-day activities.
* Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participating in audits and inspections, and proactively highlighting any issues around compliance.
About This Role
This position requires a strong understanding of sterile manufacturing processes, a focus on delivery and results within highly regulated controlled environments, and experience with Lean Six Sigma methodology.
Requirements
* Bachelor's Degree or higher preferred in a Science, Engineering, or other Technical Discipline.
* 3-5 years' operations 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.