Smith & Nephew

Process Engineer II

Smith & Nephew$80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Biology, Process Engineering, Chemical Sciences, or related field; advanced degree preferred
  • 2-5 years of experience in pharmaceutical or biotechnology manufacturing
  • Experience in process validation and continuous improvement initiatives
  • Strong problem-solving and communication skills
  • Proficiency in Microsoft Office; knowledge of JMP preferred
  • Certifications in Lean, Six Sigma, EIT, or PE are a plus

Responsibilities

  • Support product lifecycle management activities
  • Serve as a process owner during commercial manufacturing
  • Develop and maintain batch records, SOPs, and validation reports
  • Lead investigations and change control activities
  • Drive continuous process improvements and scale-up initiatives
  • Support equipment commissioning and cleanroom validation
  • Conduct data analysis and process monitoring for trend reporting

Benefits

  • 401k Matching Program and Discounted Stock Purchase Plan
  • Flexible Personal/Vacation Time Off and Paid Community Service Day
  • Comprehensive medical, dental, and vision coverage
  • Hybrid Work Model for most professional roles
  • Hands-on training and mentorship programs
  • Discounts on fitness clubs and travel
Full Job Description
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.


  • 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!


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About Smith & Nephew

Smith & Nephew is a global medical technology company headquartered in London, England. The company designs, manufactures, and sells medical devices and products for orthopedic reconstruction, sports medicine, and trauma. Smith & Nephew operates in more than 100 countries and employs over 17,500 people worldwide. The company was founded in 1856 by Thomas James Smith and his nephew, Horatio Nelson Smith, and has grown through a series of mergers and acquisitions. Smith & Nephew's products include joint replacement systems, wound care products, and surgical instruments. The company is listed on the London Stock Exchange and is a constituent of the FTSE 100 Index.
Learn more about Smith & Nephew
Size
17,500 employees
Market Cap
$11.5 billion
Industry
Net Income
$448 million
5 Year Trend
+2.2%
Revenue
$4.5 billion

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