Process Engineer II

Life. Unlimited. At Smith+Neb 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. What will you be doing? 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. What will you need to be successful? Bachelor's degree in Biology, Process Engineering, Chemical Sciences, or a related scientific or engineering discipline. Advanced degree preferred. 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. Knowledge of statistical or trending software such as JMP is preferred. Lean, Six Sigma, EIT, or PE certifications are advantageous. You. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion and Belonging Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, learn more about Employee Inclusion Groups on our website. Your Future: 401k Matching Program 401k Plus Program Discounted Stock Purchase Plan Tuition Reimbursement Work/Life Balance: Flexible Personal/Vacation Time Off Paid Holidays Flex Holidays Paid Community Service Day Your Wellbeing: Medical Dental Vision Health Savings Account (Employer Contribution of $500+ annually) Employee Assistance Program Parental Leave Fertility and Adoption Assistance Program Flexibility: Hybrid Work Model (for most professional roles). Training: Hands On Team Customized Mentorship Extra Perks: Discounts on fitness clubs, travel and more! Equal Employment Opportunity Statement: Smith+ Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. Smith+ Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+N e unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited. #J-18808-Ljbffr Smith & Nephew