Job Title:
Process Qualification Specialist
Key Responsibilities:
* Design and author qualification validation documentation, in line with the standard approval process.
* Execute execution/development of change controls and resolve technical issues encountered during study execution.
* Engage with Production, Maintenance, and Quality representatives in assigned areas of operations during execution of Cycle Development & Performance Qualification activities.
* Perform root cause analysis of system failures, substandard performance using standard tools and methods to resolve machine and system issues.
* Support continuous improvement through Lean Six Sigma methodologies.
Requirements:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* At least 3-4 years experience in authoring, reviewing, executing and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents.
* Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting.
Benefits:
* Exception/Deviation Management and Change Control.
* Demonstratable experience of leading technical related projects.
* Knowledge of process monitoring systems, automation systems (Delta V), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
Others:
Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team orientated manner.