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.

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

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