Job Overview
The Manufacturing Systems Specialist will lead the establishment of the Manufacturing Systems team within the Operations group.
Responsibilities:
* Provide expert support to the manufacturing department in SAP, LIMS, Trackwise and Finite Scheduling.
* Process and System owner for Manufacturing benchtop equipment.
* Collaborate with relevant departments on all aspects of benchtop equipment qualification lifecycle (URS to decommissioning).
* Coordinate vendor visits on site for bench top support, qualification and maintenance as needed.
* Support technical transfer and process validation.
* Ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
* Communicate operational status regularly to senior management.
Requirements:
* More than 2 years in biopharmaceutical manufacturing.
* Experience with GMP systems such as SAP and Benchtop equipment qualification and operation etc.
* Ideally have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control.
* Experience in working with cross-functional teams.
* Strong team leader with the demonstrated ability to manage and support manufacturing operations in a flexible and dynamic environment.