Senior Manager, Process Engineering
Novartis
11 days ago
On-site
Durham, NC
Operations
Key Responsibilities:
- Define and evolve lifecycle engineering strategies for large-scale biologics process and laboratory equipment
- Lead design, configuration, and integration of custom-engineered manufacturing systems supporting biotechnology processes
- Oversee commissioning and qualification activities to ensure equipment readiness, compliance, and operational performance
- Provide technical expertise on biologics process equipment across upstream and downstream manufacturing systems
- Partner with Manufacturing Science and Technology, Operations, and Quality on process performance and technology transfer
- Support startup of new manufacturing facility, ensuring successful equipment installation, testing, and qualification
- Own lifecycle strategies to optimize equipment performance and long-term manufacturing capability
- Lead root cause investigations and implement sustainable solutions for complex process equipment issues
- Develop technical specifications including user requirements, functional, and detailed design specifications
- Drive equipment upgrades and continuous improvement initiatives to support evolving process and capacity needs
Essential Requirements:
- Bachelor’s degree in Chemical, Biochemical, Mechanical, or related engineering field with 9+ years relevant experience
- Experience in process engineering or manufacturing science within biologics or pharmaceutical manufacturing environments
- Expertise supporting large-scale biologics manufacturing equipment (upstream and/or downstream)
- Experience with equipment design, commissioning, and qualification, from concept through operational readiness
- Experience working with custom-engineered equipment supporting biotechnology processes
- Experience supporting facility startup, expansion, or technology transfer in a regulated environment
- Strong knowledge of GMP and regulatory requirements for biologics manufacturing systems
- Ability to analyze process and equipment performance data to drive optimization and continuous improvement
Desirable Requirements:
- Experience supporting large-scale biologics manufacturing
- Experience with stainless-based equipment manufacturing facilities for large-scale biologics production
Benefits (as stated):
- Salary expected: $114,100–$211,900/year; performance cash incentive; potential annual equity awards; comprehensive benefits package; time off package
Application instructions:
- Send accommodation requests by email to [email protected] or call +1(877)395-2339 and include the job requisition number.
- Define and evolve lifecycle engineering strategies for large-scale biologics process and laboratory equipment
- Lead design, configuration, and integration of custom-engineered manufacturing systems supporting biotechnology processes
- Oversee commissioning and qualification activities to ensure equipment readiness, compliance, and operational performance
- Provide technical expertise on biologics process equipment across upstream and downstream manufacturing systems
- Partner with Manufacturing Science and Technology, Operations, and Quality on process performance and technology transfer
- Support startup of new manufacturing facility, ensuring successful equipment installation, testing, and qualification
- Own lifecycle strategies to optimize equipment performance and long-term manufacturing capability
- Lead root cause investigations and implement sustainable solutions for complex process equipment issues
- Develop technical specifications including user requirements, functional, and detailed design specifications
- Drive equipment upgrades and continuous improvement initiatives to support evolving process and capacity needs
Essential Requirements:
- Bachelor’s degree in Chemical, Biochemical, Mechanical, or related engineering field with 9+ years relevant experience
- Experience in process engineering or manufacturing science within biologics or pharmaceutical manufacturing environments
- Expertise supporting large-scale biologics manufacturing equipment (upstream and/or downstream)
- Experience with equipment design, commissioning, and qualification, from concept through operational readiness
- Experience working with custom-engineered equipment supporting biotechnology processes
- Experience supporting facility startup, expansion, or technology transfer in a regulated environment
- Strong knowledge of GMP and regulatory requirements for biologics manufacturing systems
- Ability to analyze process and equipment performance data to drive optimization and continuous improvement
Desirable Requirements:
- Experience supporting large-scale biologics manufacturing
- Experience with stainless-based equipment manufacturing facilities for large-scale biologics production
Benefits (as stated):
- Salary expected: $114,100–$211,900/year; performance cash incentive; potential annual equity awards; comprehensive benefits package; time off package
Application instructions:
- Send accommodation requests by email to [email protected] or call +1(877)395-2339 and include the job requisition number.