Manufacturing Technology Operations Job at DNA Life Sciences, Raleigh, NC

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  • DNA Life Sciences
  • Raleigh, NC

Job Description

Responsibilities:

The Manufacturing Technology Operations (MTO) project support role will be responsible for assisting in daily activities related to the internal large-scale manufacturing (LSM) modernization project bringing MES and electronic batch record implementation to the site. This role will work with the current internal MTO group to support site documentation activities, meeting attendance, action tracking, design questions and batch record traceability mapping in addition to other assignments as required by group management. This role is technical in nature and requires a strong understanding of drug substance manufacturing and documentation generation and processing within a digital document management system. This role will interact with newly designed / validated MES system and the associated documentation supporting these systems.

Requirements:

  • Bachelor’s degree in engineering, science, or other technical field of study
  • Proven work experience within a manufacturing technical operations support group or other similar role with 5 or more years of experience within the pharmaceutical, biotech industry
  • Experience working in a large molecule, drug substance facility
  • Experience working on or with Manufacturing Electronic Systems (MES) or electronic batch records implementation projects is desired
  • Familiarity with regulatory requirements in the pharmaceutical industry (GMP, FDA, EMA)
  • Strong technical writing skills

Job Tags

Work experience placement,

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