Summer Intern, Validation
Sanford, NC 27330 US
Job Description
The validation department is responsible for ensuring the equipment and practices used in the manufacturing of novel therapeutics meet user specifications and regulatory requirements. Our group is currently a team of three with plans for future growth as our group moves closer to clinical and commercial production. Like most departments in Sanford, we work primarily on site and have a great dynamic focused on the common goal of producing first-of-kind therapies for genetic diseases.
Intern Position Summary
The NC Validation Department is seeking a summer intern to join the team for a project in which temperature trend data will be collected and used to establish proper alarm operating parameters at our new Gene Therapy manufacturing facility in Sanford, NC.
Intern Job Responsibilities/Deliverables
The primary project for the candidate selected will be to interpret raw temperature data collected during system qualifications. The purpose of the project is to formulate temperature trends to determine the optimal alarm delay times to be programmed into the sites environmental monitoring system. Secondary responsibilities will be working with an experienced validation engineer to design and execute qualification tests and studies to mitigate any gaps identified during the data analysis.
Intern Qualifications and Skills
- Pursuing a bachelor’s or master’s degree in life sciences
- Must have an interest in pursuing a career in Life Sciences/Biotech/Pharmaceuticals
- Ability to manage workload effectively including planning, organizing, prioritizing, and meeting deadlines
- Prefer an undergraduate candidate with at least one year of school left in an engineering, life sciences or data analytics field of study.
- Ability to think creatively and excellent writing prowess
- Benefits of the Internship
The intern candidate will be given the opportunity to embed themselves within the validation department to learn and participate in the commissioning and qualification activities required to deliver a compliant, Good Manufacturing Practice (GMP) facility. The candidate will use data-driven decisions to provide a recommendation in the form of a final technical report on ideal system alarm delay times. The report generated may be presented to regulators during board-of-health audits in defense of system alarming practices. The candidate will be exposed to a fast-paced environment with the opportunity to learn and gain hands-on experience in readying a gene therapy facility for GMP use.
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