Overview
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/ ).
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Job Type: Full-time
Pay: $110,000.00 - $115,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Experience level:
Schedule:
Work setting:
Experience:
- Project management: 3 years (Required)
- FDA regulations and ISO regulatory: 3 years (Required)
Ability to Relocate:
- Memphis, TN 38116: Relocate before starting work (Required)
Work Location: Hybrid remote in Memphis, TN 38116