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Job: Manufacturing Quality Engineer, Medicago USA, Durham, NC

General Information

Job title:
Manufacturing Quality Engineer
Job location:
Durham, NC  27709 United States
Requisition code:
Date posted:
Job category:
Product Development
Agricultural Biotechnology
Facilities & Maintenance
Manufacturing and Production
Materials Management
Medical Affairs
Process Development
Employment type:
Full time

Job Description

Under the supervision of an Industrial Process Manager or Director of Industrial Process, the candidate is responsible for execution of activities supporting biopharmaceutical production. Responsibilities involve documentation development, training coordination and supporting day-to-day biopharmaceutical production.
• Independent process/project leadership
• Lead the generation and resolution of process deviations and change controls for production departments, including writing investigations, CAPAs and change controls and assisting other production personnel with completion of quality events.
• Participate/lead development of master documentation, and process improvements
• Develop process training curriculum, monitor training needs of department(s), and provide required training
• Support process floor operations as needed.
• Participate in batch record review and production floor walk-throughs

• Experienced in pilot or large scale fermentation, clarification, and/or purification operations
• Able to collaborate closely with colleagues outside their immediate department to meet critical production timelines
• Ability to train a team to meet day-to-day and long term objectives
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors in a production environment
• Able to document activities in scientific/regulatory reports and generate documents and methods to support manufacturing operations
• Experienced in establishing cGMP compliant production systems and writing the supporting documentation
• Provides input and process leadership in a fast-paced team environment
• Experience with flexible/disposable single-use systems is a plus
• Occasionally required to stand, for up to 6 hours a day; walk; reach with hands and arms and stoop, kneel, crouch or crawl. Ability to lift 30 - 50 pounds and move equipment

Job Requirements

• Technical degree with a minimum of 9 years’ experience or University degree with a minimum of
7 years’ experience or equivalent.
(Job number: 3848057)
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