As a key member of our team, you will be responsible for providing process, technical, and validation support to operations for Process Simulation development and execution.
Job Description:
* Design, author, review, approve, and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
Key Responsibilities:
* Authorise, review and approve 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 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 and substandard performance using standard tools and methods to resolve machine and system issues.
* Implement subsequent corrective action 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 the performance of 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.