Process Engineer II – Biotech Manufacturing & Innovation

smithnephew; Fort Worth (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

401k Matching Program

Discounted Stock Purchase Plan

Tuition Reimbursement

Paid Holidays

Flex Holidays

Job summary

Smith+Nebhu in Fort Worth, TX is seeking a Process Engineer 2 to support product lifecycle management, technology transfers, process validation, investigations, and continuous improvement across manufacturing operations.

The role collaborates with Manufacturing, Quality, Regulatory Affairs, Engineering, R&D, and Project Management to drive process improvements, ensure product quality, and deliver life-changing therapies; a Bachelor’s degree and 2–5 years of pharma experience are required, with a

Qualifications

• Bachelor's degree in Biology, Process Engineering, Chemical Sciences, or related discipline.
• 2 to 5 years of experience in pharmaceutical/biotech manufacturing.
• Experience with manufacturing processes, validation, equipment qualification, investigations, and continuous improvement.
• Strong problem solving, communication, and cross-functional collaboration.
• Experience with Microsoft Office; JMP knowledge preferred.
• Lean, Six Sigma, EIT, or PE certifications are advantageous.

Responsibilities

• Support product lifecycle management including technology transfers and new product introductions.
• Serve as process owner during commercial manufacturing and provide technical support.
• Develop, review, and maintain batch records, SOPs, validation protocols, and related documentation.
• Lead investigations, CAPAs, change controls, and risk assessments.
• Drive process improvements, scale-up initiatives, and efficiency projects.
• Support equipment commissioning, qualification, validation, and monitoring systems.
• Conduct stability studies, process monitoring, data analysis, and annual trend reporting.
• Collaborate with Manufacturing, Quality, Regulatory, Engineering, R&D, Project Management, and other teams.

Skills

Problem solving

Communication

Collaboration

Education

Bachelor's degree in Biology

Bachelor's degree in Process Engineering

Bachelor's degree in Chemical Sciences

Advanced degree preferred

Tools

Microsoft Office

JMP

Job description

Smith+Nebhu in Fort Worth, TX is seeking a Process Engineer 2 to support product lifecycle management, technology transfers, process validation, investigations, and continuous improvement across manufacturing operations.

The role collaborates with Manufacturing, Quality, Regulatory Affairs, Engineering, R&D, and Project Management to drive process improvements, ensure product quality, and deliver life-changing therapies; a Bachelor’s degree and 2–5 years of pharma experience are required, with a