Novartis
biopharmaceutical
SeniorEngineer,MS&T
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Engineer, MS&T at Novartis. Skills: process improvements, sterile drug product manufacturing, manufacturing issues, process verification data, product quality, production schedules, drug supply, critical quality attributes, process parameters, variability and drift, new equipment, systems, and manufacturing processes, updates to manufacturing processes, remediation and process enhancement initiatives, technology transfer, compliant GMP manufacturing, compliant and inspection-ready product”
What You'll Achieve.
ensure quality, efficiency, and reliability; ensure consistent product quality; maintain reliable drug supply; control variability and drift; ensure seamless transition into compliant GMP manufacturing; maintain a compliant and inspection-ready production environment
Industry & Context.
solve complex challenges; Lead process investigations to resolve manufacturing issues; apply scientific principles to solve complex process issues
This position will be located in Durham, NC and will be an onsite role., Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
What They're Looking For.
Must Have
Bachelor of Science degree with 6 years, Master of Science with 4 years, or PhD with 2 years of biopharmaceutical manufacturing experience, experience supporting GMP drug product manufacturing environments, including aseptic processing and fill/finish operations, Proven ability to analyze data and apply scientific principles to solve complex process issues, Excellent written and verbal communication skills with technical writing capability, Demonstrated ability to collaborate effectively across cross-functional teams, Familiarity with global regulatory requirements for drug products, validation, and qualification, Ability to manage multiple priorities and contribute to continuous improvement initiatives
Nice to Have
Skills Desired: Applied Statistics, Change Control, Data Analytics and Digital, GDP Knowledge, gmp knowledge, HSE Knowledge, Manufacturing Process, Manufacturing Production, Manufacturing Technologies, Operational Excellence, Process and Cleaning Validation, Process Control, Quality Compliance, Regulatory Compliance, Resilience and Risk Management, Technical Leadership, Technology Transfer
What You'll Do.
Lead process investigations to resolve manufacturing issues and drive continuous improvements
Analyze process verification data to identify trends and ensure consistent product quality
Partner with manufacturing to meet production schedules and maintain reliable drug supply
Monitor critical quality attributes and process parameters to control variability and drift
Implement process improvements in collaboration with operations and engineering teams
Support startup and qualification of new equipment
and manufacturing processes
Document and manage updates to manufacturing processes in compliance with quality standards
Provide technical expertise for projects
including remediation and process enhancement initiatives
Support technology transfer to ensure seamless transition into compliant GMP manufacturing
Collaborate with Quality to maintain a compliant and inspection-ready production environment
How You'll Work.
Team & Collaboration
Partnering cross-functionally; Implement process improvements in collaboration with operations and engineering teams; Collaborate with Quality to maintain a compliant and inspection-ready production environment; Demonstrated ability to collaborate effectively across cross-functional teams
Communication Scope
Excellent written and verbal communication skills with technical writing capability
Process & Methodology
Ability to manage multiple priorities
Full Job Description
**Job Description Summary** Step into a high-impact role where your expertise will directly shape the delivery of life-saving therapies. As a key member of Manufacturing Science and Technology, you’ll lead process improvements and drive innovation in sterile drug product manufacturing, partnering cross-functionally to ensure quality, efficiency, and reliability. This is your opportunity to solve complex challenges, influence production outcomes, and play a critical role in bringing medicines to patients. **Job Description** **Location:** * This position will be located in Durham, NC and will be an onsite role. * Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. **Key Responsibilities:** * Lead process investigations to resolve manufacturing issues and drive continuous improvements * Analyze process verification data to identify trends and ensure consistent product quality * Partner with manufacturing to meet production schedules and maintain reliable drug supply * Monitor critical quality attributes and process parameters to control variability and drift * Implement process improvements in collaboration with operations and engineering teams * Support startup and qualification of new equipment, systems, and manufacturing processes * Document and manage updates to manufacturing processes in compliance with quality standards * Provide technical expertise for projects, including remediation and process enhancement initiatives * Support technology transfer to ensure seamless transition into compliant GMP manufacturing * Collaborate with Quality to maintain a compliant and inspection-ready production environment **Essential Requirements:** * Bachelor of Science degree with 6 years, Master of Science with 4 years, or PhD with 2 years of biopharmaceutical manufacturing experience * Strong experience supporting GMP drug product manufacturing environments, including aseptic processing and fill/finish operat
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