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Latitude, Inc. Sr Manufacturing Technicians in Burtonsville, Maryland

Have immediate openings for Manufacturing Techs with a background in bio-tech organizations and solid GMP practices.

Responsibilities:

  • 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

Requirements

  • Minimum of 3 years' experience in 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 life-cycle execution of Process Orders on the shop floor including:

  • Staging of materials / components from the main warehouse to Production Storage Locations on the shop floor.

  • Consumption of materials / components to executable Process Orders.

  • Confirmation of Labor Hours against active Process Orders.

  • 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.

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