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

The Senior Cleaning Validation Engineer is responsible for managing, planning, and executing cleaning validation projects in compliance with corporate and regulatory requirements. Assist Cleaning Validation Manager/Project Manager, Cleaning Validation Engineers, Cleaning Subject Matter Experts (SME), and engineers as needed to support Global Orthopaedic franchises/sites with activities related to cleaning validation to maintain compliance to regulatory and S+N corporate requirements.

What will you be doing?

• Leads, plans, and executes Memphis cleaning validation projects.

• Supports Global Orthopaedic sites with cleaning validation related activities as needed: (i.e., regulatory and corporate compliance, planning, troubleshooting, training, etc.)

• Ensure that cleaning validation projects are compliant to corporate procedures and regulatory requirements, including the medical device FDA Quality System Regulations (QSR) and ISO (i.e., ISO 13485, ISO 19227).   

• Supports internal and external customer inquiries and opportunities.

• Coordinates and conducts risk assessments required by the validation program.

• Applies statistical tools to determine sampling plans and to analyze data associated with validation activities.

• Assist in management of validation records/documentation.

• Performs and directs process validations, IQ, OQ, and PQ as required.

• Assist with administering validation training as required.

• Collaborate with Project Managers, Validation Engineers, and Quality/Manufacturing engineers to review processes, determine validation requirements, coordinate the validation.

• Coordinates and performs testing relating to the cleaning validation as required.

• Works with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems associated with cleaning validations.

• Performs and supports internal and external audits associated with cleaning validation activities.

• Writes validation protocols and reports as required.

• Works across diverse teams.

• Performs other duties as assigned.

Responsibilities:

• Manage, execute, and support cleaning projects (30 %)

• Write protocols, reports, execute testing. (30%)

• Provide guidance, collaborate across multifunctional teams for planning and determining required cleaning validation activities for projects. (20%)

• Support internal and external customer inquiries. (10%)

• Other as required. 10%

What will you need to be successful?

• Education:

  • Bachelor of Science degree in a scientific field or in life sciences required. 

• Experience:

  • 5+ years experience in cleaning validation planning, execution, testing.

  • 4+ years project management experience or education in project management.  

  • A thorough understanding of FDA QSR and ISO regulatory environment.

  • Audit experience is a plus

• Excellent organizational and time management skills.

• Excellent verbal and written communication skills.

• Ability to work independently.

• Technical writing.

• Proficiency in Windows and Microsoft Office Applications (i.e., Word, Excel, Outlook, MS Teams)

• Travel Requirements: <10%

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- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future:  401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance:  PTO, 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.