We are currently recruiting for a key role with a leading international organization. This is an exceptional opportunity for individuals looking to join a global business leader.
* Compliance documentation, risk assessments, and audit participation are required tasks.
* Process engineering and validation
* Lead technical transfer support by executing process engineering and validation activities.
* Manage multiple technical projects, including process improvements, capital projects, and Lean initiatives.
* Deliver on all technical/Validation/Quality Notifications/Change control/Project support within the team.
* Develop risk-based approaches to investigations and troubleshooting.
* Encourage lean six sigma and standard work within the team.
* Drive collaboration between functions and identify innovative solutions.
* Act as a subject matter expert in equipment design, C&Q execution, and process design/validation.
Considerable experience in a comparable role is necessary. A strong background in process engineering and/or validation in a sterile manufacturing environment is also essential. Experience leading through change and implementing process improvements is advantageous.
In-depth knowledge of sterile filling processes and equipment, especially aseptic processing, is required. Good shipping/filter/cleaning validation knowledge and automation/MES expertise are also essential. Proven records of process improvement implementation and project management are beneficial.