Job Title: Process Engineer
We are seeking a highly skilled and experienced Process Engineer to join our team. The successful candidate will be responsible for delivering technical support to the Drug Substance Business, leading technical investigations and supporting significant projects across the site.
Key Responsibilities:
* Ensure compliance with Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP).
* Design, author, review, approve, and execute qualification documentation.
* Lead experimental design, execution, data analysis, and interpretation.
* Author and review batch documentation, regulatory, and technical documentation.
* Interpret trends observed in commercial process monitoring and for further technical investigations and process changes.
* Support the execution of development and PPQ batches, change control management, and implementation.
* Lead multidisciplinary teams for process improvement and troubleshooting.
* Participate in audits and inspections.