NCBiotech
Sr. Technical Documentation Specialist, MES Implementation
NCBiotech, Durham, North Carolina, United States, 27703
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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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
#J-18808-Ljbffr