Process Simulation Technical Engineer
We are currently seeking an experienced Process Simulation Technical Engineer to provide technical support for process simulation development and execution. The ideal candidate will have 3-5 years experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.
Key Responsibilities:
1. Design/author/review/approve/execute process simulations studies in support of new product introduction and ongoing manufacturing support.
2. Provide technical input into quality notifications by authorizing/reviewing/approving Process Simulation related investigations.
3. Design/author/review/approve/execute process simulation qualification/validation documentation and studies in line with the standard approval process.
4. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
5. Support continuous improvement through Lean Six Sigma methodologies.
6. Leading and active participation in projects, system failure investigations and investigation reports,
7. Execution/development of change controls to support the Process Simulation process.
8. Contribution to Kaizen events as appropriate.
9. 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 why's etc.;
10. Implement subsequent corrective action through the change management system.
11. Serve as technical engineering representative for internal technical group discussions and represent technical operations at global technical forums in relation to process simulations.
12. Participate and/or lead cross-functional or single-function teams including liaising with vendors or above-site groups.
13. 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.
14. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections, and proactively highlighting any issues around compliance.
15. Work collaboratively to drive a safe and compliant culture.
16. May be required to perform other duties as assigned.