Process Engineer II

Posted Yesterday
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Fort Worth, TX, USA
In-Office
Mid level
Healthtech • Biotech
The Role
Support manufacturing process ownership, technology transfers, product introductions, validation, investigations, CAPAs, change controls, process improvements, equipment qualification, stability studies, data analysis, and trend reporting. Collaborate with Manufacturing, Quality, Regulatory Affairs, Engineering, R&D, and Project Management teams to improve operational performance and product outcomes.
Summary Generated by Built In

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.
 

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!
#LI-ONSITE

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.

Stay connected by joining our Talent Community.

We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.  

Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.

Explore our website and learn more about our mission, our team, and the opportunities we offer. 

 

Skills Required

  • Bachelor's degree in Biology, Process Engineering, Chemical Sciences, or a related scientific or engineering discipline
  • 2 to 5 years of experience, preferably in pharmaceutical or biotechnology manufacturing
  • Experience supporting manufacturing processes, process validation, equipment qualification, investigations, and continuous improvement initiatives
  • Strong problem-solving, communication, and cross-functional collaboration skills
  • Experience with Microsoft Office applications
  • Knowledge of statistical or trending software such as JMP
  • Advanced degree
  • Lean, Six Sigma, EIT, or PE certifications

Smith & Nephew Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Smith & Nephew and has not been reviewed or approved by Smith & Nephew.

  • Healthcare Strength Medical, dental, and vision plans are paired with a global mental‑health program for employees and families, indicating a robust core health package.
  • Retirement Support U.S. employees have access to a 401(k) with company contributions, and share plans complement long‑term savings.
  • Leave & Time Off Breadth Generous holiday, paid volunteering leave, and flexible work models point to broad time‑off options.

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The Company
Andover, MA
15,318 Employees

What We Do

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+Nephew a 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. Please note: not all products referred to may be approved for use or available in all markets.

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