Process Engineer II

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

The Process Engineer 2 primarily supports Product Lifecycle Management for the Fort Worth - Vickery site. This includes Technology Transfer (new product introductions and product reintroductions) into Manufacturing, process owner during commercial manufacturing, process improvements, process and material characterization, validation activities, among other activities related to each manufacturing process at the site. This role supports manufacturing investigations related to product impact, change control justifications and identification/implementation of process improvements.

Additionally, this role will evaluate existing processes and configuring manufacturing systems to improve sustainability and develop standard methodologies within the production process. Job requirements for this role will include but not limited to, assisting in URS development, FAT execution, installation / commissioning support, PQ / Process Validation development and execution, SOP development, production support, and efficiency improvement initiatives.

What will you be doing?

• Responsible for all aspects of the different manufacturing processes. Contribute to the authorship of and/or owner of Manufacturing Batch Records, Process SOPs, Process Validation Protocols and Reports, Quality Control method transfers, Process Characterization Summary Reports, Regulatory Affairs filing / data collection and any process related compliance documents. Directly involved with the commissioning of any new manufacturing equipment monitoring and alarm systems, or execution of validation protocols in the clean-rooms as requested.
• Review and/or approval of Manufacturing Change Controls, Validation protocols, and CAPAs. Investigate or provide oversight for any deviations with potential for product impact. Implement CAPAs, Change Controls as needed. Lead risk assessments to support any observation responses, CAPAs, etc.
• Identify and implement process improvement / scale-up / process efficiency change controls and associated development/test protocols. Conduct Stability studies and temperature control experiments to substantiate and/or produce data to support temperature and storage condition labeling.
• Ensure compliance with Site Validation Master Plan by coordinating all activities such as cleaning validation/monitoring, periodic requalification/revalidation, and/or periodic validation assessment.
• Annual statistics / process control charting.

What will you need to be successful?

• Bachelor of Science in Engineering, Biology, or Chemical Sciences.
• Minimum of 3 years' experience in a Pharmaceutical/Biotech environment or 2 years in a Process Engineer role.
• Knowledge in cycle development for autoclave and CIP.
• Project Management experience a plus.
• Communications skills, including interaction with diverse fields such as R&D, Engineering, Manufacturing, Quality, Regulatory Affairs, Project Management, and general management.
• Ability to identify problems and find solutions, as well as express those problems appropriately to management when required.
• Digital literacy including familiarity with Microsoft Word, Power Point, Excel, and Access. Ability to work with trending software such as JMP is preferred.
• Reading comprehension and attention to detail.
• Ability to act independently to carry out tasks given by management in the time allotted.
• Proven ability to learn new tasks and adapt to new situations.

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.