Job Title: Manufacturing Systems Specialist
This role is a pivotal position within the manufacturing operations department.
Responsibilities:
* Provide expert support to the manufacturing team in areas of SAP, LIMS, Trackwise and Finite Scheduling.
* Process and system owner for manufacturing benchtop equipment.
* Maintain all manufacturing benchtop equipment in a qualified state by collaborating with relevant departments on qualification lifecycle.
* Coordinate vendor visits on site for bench top support, qualification and maintenance as needed.
* Offer input on systems planning.
* Collaborate with MT and MSAT groups on technical transfer and process validation.
* Work with QC & QA teams to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
* Support training regarding benchtop equipment troubleshooting.
* Ensure current, accurate and clear MFG documentation (SOPs MBRs, OJTs) for areas of responsibility.
The ideal candidate has experience in biopharmaceutical manufacturing, GMP systems and cross-functional collaboration. Strong leadership skills are essential.