Solution Engineer Responsibilities
The Solution Engineer is responsible for ensuring the reliable operation and qualified state of clean utility systems and supporting grey systems that support biotech manufacturing.
Key Responsibilities:
* Ensure a safe working environment by following safety rules and helping improve the safety culture.
* Provide clean system engineering expertise as an active member of area team.
* Clean system unit operations and equipment are maintained and are in a qualified and reliable state.
* Establish and/or monitor the critical parameters for all clean systems to ensure that these are in control.
* Lead Troubleshooting efforts to resolve difficult unit operations, equipment and operational issues.
* Evaluate all activities for impact on qualified state of equipment and utilize appropriate tools as necessary.
* Supporting the grey utility.
Safety:
Take responsibility for the safe design and safe operation of the equipment within the area.
Actively participate in safety-related activities (audits, hazard reviews, pre-start up safety reviews) to drive ongoing safety improvement.
Bio-process Technical Support:
Be the point of contact and be the technical expert for equipment and processes in area of responsibility.
This includes clear understanding of unit operations and associated equipment operations.
Monitor the utility systems and optimise the unit operations and equipment performance.
Lead troubleshooting efforts relating to unit operations, equipment and operational issues.
Utilise formal problem solving techniques, including Root Cause Analysis, to resolve unit operations and equipment issues.
Respond to unit operations issues and equipment failures, document appropriately and ensure resolution of events through appropriate actions.
Communicate effectively with others, especially team members, operations and crafts personnel.
Maintained Qualified State:
Evaluate all activities for impact on qualified state of unit operations/equipment and utilise appropriate business processes as necessary (change control etc).
Responsible for system/component classification and maintenance strategy for equipment.
Implement corrections, corrective actions, and countermeasures arising from investigations.
Participate in Periodic Reviews for systems and equipment.
Lead IQ/OQ/PQ activities (including commissioning activities of new unit operations/equipment).