Process Engineer

Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.

The Process Engineer 1 is responsible for ownership of Operations NCs, CAPAs, document review, and document revisions at the Fort Worth Facility to ensure the systems function in compliance with corporate and regulatory agency requirements.

What will you be doing?

• Responsible for investigating and drafting operations NCs and CAPAs using problem solving methodology.
• Generate trending metrics for non-conformances, CAPAs, and other metrics as needed both qualitatively and quantitatively.
• Authority on all related procedures, ensuring compliance to the relevant corporate procedures.
• Draft and revise Operations SOPs, Batch records, specifications, and training material as needed.
• Assist Manufacturing Engineering teams with improvement initiatives including equipment qualifications and process qualifications.
• Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results.
• Audit Manufacturing processes to ensure compliance to procedures.
• Assists with audit activities as required, including follow-up activities.
• Aligns with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Other additional responsibilities, as required.

What will you need to be successful?

• Bachelor’s Degree in life science, engineering, or related field.
• Experience associated with a Pharmaceutical GMP manufacturing environment preferred.
• Having a CAPA background; ownership of NC/CAPA preferred.
• Strong computer, scientific, and organizational skills. High level of PC skills. Proficiency in Microsoft Word, Excel, and other presentation software
• Strong planning, organizational, critical thinking, and problem-solving skills.
• Proven track record managing inward and out bound supply chain to tight deadlines.
• Excellent interpersonal skills.
• Travel Requirements: 0 - 5%.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

• Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).
• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, 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+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.