Process Engineer II

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

Life. Unlimited. At Smith+Nebhu 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.

• 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!

Smith+Nebhu 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.