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Sr. Technical Documentation Specialist, MES Implementation
Sr. Technical Documentation Specialist, MES ImplementationNCBiotech • Durham, NC, US
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Sr. Technical Documentation Specialist, MES Implementation

Sr. Technical Documentation Specialist, MES Implementation

NCBiotech • Durham, NC, US
17 hours ago
Job type
  • Full-time
Job description

Overview

Randstad Enterprise is looking for a motivated, experienced Manufacturing Technical Writer to jump in and support the Large-Scale Manufacturing with updating the electronic batch records and electronic equipment tracking after a MES modernization project.

Previous experience in authoring of manufacturing technical instructions and batch records is a MUST HAVE along with 5+ years of experience in order to have an in depth understanding of scientific concepts to translate information effectively.

Benefits

  • 100% onsite in RTP
  • Contract : 6+ months (with extension potential or full-time opportunities)
  • Benefits available through Randstad

Responsibilities

  • Main focus of the Job : 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.
  • Work with the MTO group to support site documentation activities, meeting attendance, action tracking, design questions and batch record traceability mapping.
  • Requires a strong TECHNICAL understanding of drug substance manufacturing and documentation generation and processing within a digital document management system.
  • You will be interacting with newly designed / validated MES system and the associated documentation supporting these systems.

    • Needed for Success

  • 5 or more years of experience within the pharmaceutical, biotech industry with proven work experience within a manufacturing technical operations support group
  • Experience working in a large molecule, drug substance facility
  • Experience working on or with Manufacturing Electronic Systems (MES) or electronic batch records implementation projects
  • Familiarity with regulatory requirements in the pharmaceutical industry (GMP, FDA, EMA)
  • Amazing technical writing skills and attention to details.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
  • Strong analytical and problem-solving skills.
  • Proficiency in myCIMS or Veeva document management systems a plus

    • Education

    B.S. Degree in Engineering or Scientific Disciplin

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