GMP Technical Services Engineer

NCBiotech; Wilmington (NC); On-site; USD 55,000 - 85,000; Full time

Job summary

NCBiotech is seeking a manufacturing associate to support GMP Synthesis, Manufacturing and Formulation Services. The role focuses on batch records, cleaning documentation, and process validation in a fast-growing environment.

You will collaborate with manufacturing, QA, validations, metrology and business development to keep facilities compliant, transfer processes, and deliver timely results while maintaining client confidentiality.

Qualifications

• Associate degree or higher in a scientific or engineering discipline.
• At least 3 years of experience or equivalent education/experience.

Responsibilities

• Initiate or revise batch records for products and processes.
• Create documents for and execute cleanability studies.
• Create and maintain cleaning documentation for products and processes.
• Create documents for and work with manufacturing and formulations team to execute DOE studies.
• Create technical transfer documentation for products and processes.
• Develop Standard Operating Procedures and training materials for manufacturing processes, as applicable.
• Create documents for and execute process and product validations.
• Perform batch data trending and write reports, change requests, and deviations (as required).
• Assist in the production and packaging of R&D and GMP products, as required.
• Work with the manufacturing, validations and metrology teams to maintain equipment, utilities and facility in a ready state of compliance including keeping them clean, calibrated and qualified.
• Monitor viewLinc (environmental monitoring system) and respond to excursions as needed.
• Work with clients to transfer in/out products and processes.
• Assist in the performance and trending of environmental monitoring of the GMP Synthesis, Manufacturing and Formulation Services areas.
• Maintain strict client confidentiality.
• Work with manufacturing and formulation management to investigate aberrant data.
• Work with quality group to ensure compliance for all GMP work.
• Work with Business Development and management to develop timelines for work activities.
• Communicate daily with manufacturing and formulation management about work scheduling and project progress/results.

Education

Associate degree or higher in a scientific or engineering discipline

Job description

NCBiotech is seeking a manufacturing associate to support GMP Synthesis, Manufacturing and Formulation Services. The role focuses on batch records, cleaning documentation, and process validation in a fast-growing environment.

You will collaborate with manufacturing, QA, validations, metrology and business development to keep facilities compliant, transfer processes, and deliver timely results while maintaining client confidentiality.