job summary: A Manufacturing Technical Writer is needed for a multinational biotechnology company that specializes in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide in the Durham, NC area. This role will support the Large-Scale Manufacturing (LSM) MES modernization project in RTP by authoring and updating electronic batch records and equipment tracking documentation with a strong focus on drug substance manufacturing. location: Durham, North Carolina job type: Contract salary: $40.84 - 48.00 per hour work hours: 8am to 5pm education: Bachelors responsibilities: 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 the newly designed / validated MES system and the associated documentation supporting these systems. Skills: 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 and Experience: B.S. Degree in Engineering or Scientific Discipline.5 or more years of experience within the pharmaceutical, biotech industry with proven work experience within a manufacturing technical operations support group. #LI-SS6 qualifications: Experience level: ExperiencedEducation: Bachelors skills: ManufacturingGMP Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days.