Novartis

Biologics Manufacturing

SeniorManager,ProcessEngineering

$114–114k Durham, North Carolina, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Senior Manager, Process Engineering at Novartis. Skills: Process Engineering, Biologics Manufacturing, Equipment Lifecycle. Define lifecycle engineering strategies. Evolve lifecycle engineering strategies”

What You'll Achieve.

Ensure successful delivery of manufacturing capability; Ensure systems remain reliable; Ensure systems remain compliant; Ensure systems aligned with Good Manufacturing Practice

Industry & Context.

Biologics Manufacturing
Problems you'll solve

Root cause investigations; Troubleshooting; Continuous improvement

What They're Looking For.

Must Have

Bachelor's degree in Chemical, Biochemical, Mechanical, or related engineering field, 9+ years relevant experience, Experience in process engineering or manufacturing science within biologics or pharmaceutical manufacturing environments, Expertise supporting large-scale biologics manufacturing equipment, Experience with equipment design, commissioning, and qualification, Experience working with custom-engineered equipment supporting biotechnology processes, Experience supporting facility startup, expansion, or technology transfer in a regulated manufacturing environment, Knowledge of Good Manufacturing Practice and regulatory requirements, Ability to analyze process and equipment performance data

Nice to Have

Experience supporting large-scale biologics manufacturing, including upstream or downstream process systems, Experience supporting stainless based equipment manufacturing facilities

What You'll Do.

Define lifecycle engineering strategies

Evolve lifecycle engineering strategies

Lead design of manufacturing systems

Lead configuration of manufacturing systems

Lead integration of manufacturing systems

Oversee commissioning activities

Oversee qualification activities

Provide technical expertise on biologics process equipment

Partner with Manufacturing Science and Technology

Partner with Operations

Support startup of new manufacturing facility

Ensure successful equipment installation

Ensure successful equipment testing

Ensure successful equipment qualification

Own lifecycle strategies

Optimize equipment performance

Optimize long-term manufacturing capability

Lead root cause investigations

Implement sustainable solutions for process equipment issues

Develop technical specifications

Develop user requirements

Develop functional specifications

Develop detailed design specifications

Drive equipment upgrades

Drive continuous improvement initiatives

How You'll Work.

Team & Collaboration

Partner with Manufacturing Science and Technology; Partner with Operations; Partner with Quality

Process & Methodology

Project Management

Full Job Description

**Job Description Summary** At Novartis, you will play a key role in shaping the future of biologics manufacturing. As a Senior Manager, Process Engineering, you will lead a team of engineers responsible for the lifecycle engineering of process and laboratory equipment, with a strong focus on equipment design, system integration, commissioning, qualification, and operational readiness. This role plays a critical leadership role in the startup of a new large molecule manufacturing facility, supporting equipment specification, installation, and qualification to ensure successful delivery of manufacturing capability. Following site startup, you will transition to driving ongoing process equipment performance, continuous improvement, and lifecycle optimization, ensuring systems remain reliable, compliant, and aligned with Good Manufacturing Practice requirements. **Job Description** #LI-Onsite **Location:** Durham, NC **Relocation Support:** This role is based in Durham, United States. Novartis is unable to offer relocation support: please only apply if accessible. **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 comple

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