GMP Process Expert — Onsite Life Sciences Manufacturing

NCBiotech; Durham (NC); On-site; USD 85,000 - 159,000; Full time

Job summary

Novartis in Morrisville, NC is seeking a Process Expert to be the go-to specialist on the shop floor, ensuring GMP-compliant manufacturing, quality, and productivity. You will troubleshoot, support production teams, and drive continuous improvement in processes and documentation.

The role demands a science degree and 2+ years in GMP manufacturing support, with broader experience (7+ years) if no degree; MES/SAP familiarity is a must. This onsite position offers a competitive benefits package.

Qualifications

• University degree in Science, preferably Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent experience.
• Minimum 2 years of experience in a GMP manufacturing process support role
• Minimum 7 years of experience of relevant field for candidates without a university degree
• Strong knowledge of GMP and regulatory requirements across multiple health authorities
• Solid scientific and technical understanding, including manufacturing and automation principles
• Experience with manufacturing systems such as MES, SAP, or similar platforms

Responsibilities

• Provide frontline expert support for process-specific issues in manufacturing operations
• Act as Subject Matter Expert for assigned products and processes
• Coordinate production activities to ensure on-time execution aligned with approved documentation
• Troubleshoot technical issues and implement effective corrective and preventive actions
• Review batch records and ensure timely completion of batch documentation
• Maintain accurate and up-to-date production documentation to support compliance and audits
• Support validation activities and changeover processes between production campaigns
• Deliver training programs and build technical capabilities of production teams
• Collaborate with training teams to define and maintain qualification standards
• Promote strong quality and health, safety, and environmental culture on the shop floor

Skills

Data Analytics

Digital skills

General Hse Knowledge

GMP knowledge

Process excellence

Resilience

Teamwork

Communication

Influencing skills

Education

Science degree

Pharmacy

Chemical Engineering

Pharmaceutical Technology

Equivalent experience

Tools

MES

SAP

Job description

Novartis in Morrisville, NC is seeking a Process Expert to be the go-to specialist on the shop floor, ensuring GMP-compliant manufacturing, quality, and productivity. You will troubleshoot, support production teams, and drive continuous improvement in processes and documentation.

The role demands a science degree and 2+ years in GMP manufacturing support, with broader experience (7+ years) if no degree; MES/SAP familiarity is a must. This onsite position offers a competitive benefits package.