Process Engineer II

Smith & Nephew•Fort Worth, TX

5d•Hybrid

About The Position

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Are you passionate about improving manufacturing processes, driving innovation, and supporting the delivery of life changing products? As a Process Engineer 2, you will play a critical role in supporting product lifecycle management, technology transfers, process validation, manufacturing investigations, and continuous improvement initiatives at our Fort Worth facility. This is an exciting opportunity to work across multiple functions and make a meaningful impact on both operational performance and patient outcomes.

Requirements

Bachelor's degree in Biology, Process Engineering, Chemical Sciences, or a related scientific or engineering discipline.
2 to 5 years of experience, preferably within a pharmaceutical or biotechnology manufacturing environment.
Experience supporting manufacturing processes, process validation, equipment qualification, investigations, and continuous improvement initiatives.
Strong problem solving, communication, and collaboration skills with the ability to work effectively across diverse teams.
Experience with Microsoft Office applications.

Nice To Haves

Advanced degree preferred.
Knowledge of statistical or trending software such as JMP is preferred.
Lean, Six Sigma, EIT, or PE certifications are advantageous.

Responsibilities

Support product lifecycle management activities, including technology transfers, new product introductions, and product reintroductions into manufacturing.
Serve as a process owner during commercial manufacturing and provide technical support across manufacturing operations.
Develop, author, review, and maintain manufacturing batch records, process SOPs, validation protocols and reports, and other process related documentation.
Lead and support investigations, CAPAs, change controls, risk assessments, and activities related to potential product impact.
Drive process improvements, process characterization studies, scale up initiatives, and manufacturing efficiency projects.
Support equipment commissioning, qualification, validation, monitoring systems, and cleanroom validation activities.
Conduct stability studies, process monitoring activities, data analysis, and annual process trend reporting.
Partner closely with Manufacturing, Quality, Regulatory Affairs, Engineering, R&D, Project Management, and other cross functional teams.