Engineer, MS&T – Aseptic Drug Product
Novartis
August 24, 2026
On-site
Durham, NC
Operations
Key Responsibilities:
- Monitor and analyze process performance data to support continued process verification and product quality.
- Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges.
- Trend critical quality attributes and process parameters to identify risks and drive improvements.
- Support technology transfer activities for new products and processes into commercial manufacturing.
- Identify and implement continuous improvement opportunities that enhance operational performance.
- Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment.
- Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply.
- Support process changes and improvements with cross-functional Engineering, Validation, and Operations teams.
- Contribute to the startup and implementation of new equipment, software, and manufacturing processes.
- Provide technical support for strategic projects, remediation initiatives, and process optimization efforts.
Essential Requirements:
- Bachelor’s in Biochemistry, Chemical Engineering, Bioengineering, or related field with 4+ years biopharmaceutical GMP manufacturing (including aseptic fill-finish); or 3+ years direct Novartis Gene Therapies experience with aseptic fill-finish; or Master’s with 2+ years relevant aseptic fill-finish or engineering experience.
- Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation/qualification principles.
- Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations.
- Strong technical writing skills for accurate, compliant documentation.
- Proven ability to collaborate across cross-functional teams and communicate with diverse stakeholders.
- Ability to travel up to 10%.
Benefits (explicitly stated):
- Salary expected range: $89,600–$166,400 annually; performance-based cash incentive; eligibility for annual equity awards (depending on level).
- US-based comprehensive benefits (health, life/disability), 401(k) match, time off (vacation, personal days, holidays, other leaves).
Application Instructions:
- Onsite in Durham, NC; no relocation support—apply only if location is accessible.
- Monitor and analyze process performance data to support continued process verification and product quality.
- Lead technical investigations and provide scientific expertise to resolve manufacturing process challenges.
- Trend critical quality attributes and process parameters to identify risks and drive improvements.
- Support technology transfer activities for new products and processes into commercial manufacturing.
- Identify and implement continuous improvement opportunities that enhance operational performance.
- Partner with Quality teams to maintain a compliant and inspection-ready manufacturing environment.
- Collaborate with Manufacturing to troubleshoot production issues and ensure reliable product supply.
- Support process changes and improvements with cross-functional Engineering, Validation, and Operations teams.
- Contribute to the startup and implementation of new equipment, software, and manufacturing processes.
- Provide technical support for strategic projects, remediation initiatives, and process optimization efforts.
Essential Requirements:
- Bachelor’s in Biochemistry, Chemical Engineering, Bioengineering, or related field with 4+ years biopharmaceutical GMP manufacturing (including aseptic fill-finish); or 3+ years direct Novartis Gene Therapies experience with aseptic fill-finish; or Master’s with 2+ years relevant aseptic fill-finish or engineering experience.
- Knowledge of GMP requirements, pharmaceutical manufacturing regulations, and validation/qualification principles.
- Experience supporting aseptic drug product manufacturing, MS&T, process engineering, or related technical operations.
- Strong technical writing skills for accurate, compliant documentation.
- Proven ability to collaborate across cross-functional teams and communicate with diverse stakeholders.
- Ability to travel up to 10%.
Benefits (explicitly stated):
- Salary expected range: $89,600–$166,400 annually; performance-based cash incentive; eligibility for annual equity awards (depending on level).
- US-based comprehensive benefits (health, life/disability), 401(k) match, time off (vacation, personal days, holidays, other leaves).
Application Instructions:
- Onsite in Durham, NC; no relocation support—apply only if location is accessible.