Band
Level 3
Job Description Summary
Join a team committed to delivering life-changing therapies to patients worldwide. As a Process Engineer III, you will provide engineering support for manufacturing equipment, facilities, and utilities, driving reliability, compliance, and continuous improvement across operations. This role offers the opportunity to lead strategic engineering initiatives, solve complex technical challenges, and apply experience with fill finish/drug product equipment and Clean-in-Place (CIP)/Steam-in-Place (SIP) systems in a dynamic pharmaceutical manufacturing environment.
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 equipment lifecycle activities to ensure compliant, reliable, and validated manufacturing operations.
- Define and optimize equipment qualification and validation strategies for new and existing systems.
- Own process equipment changes to maintain validated state and drive operational improvements.
- Investigate equipment and process deviations, implementing effective corrective and preventive actions.
- Serve as a subject matter expert during regulatory inspections and internal audits.
- Develop and implement equipment reliability and maintenance strategies that support business objectives.
- Lead capital projects and provide engineering expertise for facility and equipment enhancements.
- Create and maintain technical documentation, including User Requirements, Functional Specifications, and Design Specifications.
- Partner with Operations and Manufacturing Sciences to support new product introductions and facility fit assessments.
- Evaluate and implement innovative manufacturing technologies to support long-term site strategy.
Essential Requirements:
- Bachelor’s degree in Chemical Engineering, Electrical Engineering, Mechanical Engineering, or a related technical field.
- Minimum five years of experience in pharmaceutical or biopharmaceutical Good Manufacturing Practice manufacturing operations.
- Strong knowledge of United States Food and Drug Administration regulations and Good Manufacturing Practice systems in regulated environments.
- Excellent written and verbal communication skills, including technical documentation and report writing.
- Experience supporting manufacturing equipment, facilities, and utility systems within pharmaceutical or biotechnology operations.
- Demonstrated project management experience with the ability to lead complex initiatives and long-term planning activities.
- Proven ability to investigate technical issues, analyze data, and implement effective solutions in fast-paced environments.
- Experience leading cross-functional teams and collaborating across multiple functions to achieve business objectives.
Desirable Requirements
- Experience supporting fill finish or drug product manufacturing equipment.
- Experience with Clean-in-Place (CIP) and Steam-in-Place (SIP) systems.
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $98,700 and $183,300 annually
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
#LI-Onsite
Salary Range
$98,700.00 - $183,300.00
Skills Desired
Business Continuity, Cost Management, Operational Excellence, Quality Compliance
