Process Engineer
Job in
Winston-Salem, Forsyth County, North Carolina, 27104, USA
Listed on 2026-03-01
Listing for:
Novozen Healthcare LLC
Full Time
position Listed on 2026-03-01
Job specializations:
-
Engineering
Process Engineer, Validation Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
We are seeking a Senior Process & Mechanical Engineer with extensive experience in pharmaceutical GxP environments. The ideal candidate will have strong expertise in utility systems, commissioning, qualification, and process optimization. This role will support capital projects from design through construction, commissioning, and validation, with a strong emphasis on utility and process system performance, robustness, and efficiency.
Key Responsibilities:
- Lead and execute commissioning and qualification activities (IV/OV, IOQ) for pharmaceutical process and utility systems.
- Design, review, and optimize utility systems and associated sequences of operations.
- Develop and review process sequences for support utility systems, including chilled water, purified water, water for injection (WFI), nitrogen, and compressed air systems.
- Provide validation support for process vessels, skids, and utilities in compliance with GxP requirements.
- Support facility design and construction management activities, including system verification, troubleshooting, and turnover to operations.
- Lead or coordinate commissioning schedules and execution teams during startup of new or renovated facilities.
- Collaborate with Manufacturing, Quality, Automation, and Maintenance teams to ensure systems meet operational and regulatory requirements.
Required Qualifications:
- Bachelor’s or Master’s degree in Chemical Engineering or a related discipline.
- 8+ years of pharmaceutical GxP experience supporting facility design, construction, commissioning, and validation activities.
- Clean-in-Place (CIP) Design and Optimization
- Commissioning and Qualification (IV/OV/IOQ)
- Clean and Black Utility Systems / Process & Utility Equipment
- Pharmaceutical Validation Support
- Sequence of Operations Development
- Strong working knowledge of clean and black utility systems.
- Proven experience supporting large-scale pharmaceutical capital projects and facility startups.
- Demonstrated ability to lead cross-functional teams and manage contractors within an active manufacturing environment.
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