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
salary: $65 - $70 per hour
shift: First
work hours: 8 AM - 5 PM
education: Bachelors
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.
- Work with the MTO group to support site documentation activities, meeting attendance, action tracking, design questions and batch record traceability mapping.
- Requires an amazing 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.
- 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.
- Great analytical and problem-solving skills.
- Proficiency in myCIMS or Veeva document management systems a plus
The essential functions of this role include:
Skills
Qualifications
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.
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.
