Sr. Manufacturing/Manufacturing Associate
The Sr. Manufacturing/Manufacturing Associate will be responsible for assisting in the development of commercialization systems including end user testing of SAP modules and creation of procedures and work instructions for launch of the new SAP Commercial system at the Exton site. Post implementation, the Associate will support floor execution of manufacturing campaigns and train other operations staff to use new commercial SAP system.
Assist with the development, review, and revision of all associated controlled documents needed to utilize the SAP system as an End User including End-User Standard Operating Procedures, Work Instructions, Job Aids, etc.
Provide Development phase (DEV environment) support and feedback for all SAP elements related to Support Operations (buffer/media, and weigh/dispense)
Provide User Acceptance Testing (UAT) execution/support resource during the SAP Qualification (Q) phase
Assist with the orientation and training of additional Support Operations or Biologics staff for rolling out routine use of the qualified SAP system for production campaigns
Assist with the initial SAP end-to-end use and troubleshooting during initial GMP batch production as an End User
Contribute to the floor execution of GMP batch production in support operations or upstream/downstream processing (buffer/media prep, etc.) with appropriate technical skills, techniques, and experiences
Minimum of 3 years experience in buffer/media or upstream/downstream processing at a pharmaceutical or biotechnology company
Minimum of 3 years End-User experience and/or knowledge in SAP Process systems as used in a regulated manufacturing environment (not IT SAP role)
Knowledgeable in the lifecycle execution of Process Orders on the shop floor including:
o Staging of materials / components from the main warehouse to Production Storage Locations on the shop floor.
o Consumption of materials / components to executable Process Orders.
o Confirmation of Labor Hours against active Process Orders.
o Yield of Process Orders to inventory.
Assist in trouble-shooting of Process Order-related problems on the shop floor including missing parts, due date management and material consumption deficiencies.
Monitor inventory in buffer/media preparation and weigh/dispense suites or inventory in Upstream/Downstream suites and assist in inventory reconciliation activities
Flexibility to multi-task and adjust to varying priorities to meet timelines and schedule changes in Support or Biologics Operations.