Test Method Validation (TMV) SME

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Test Method Validation SME position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows

Position: Test Method Validation (TMV) SME

Duration: 6–9 Month Contract (Extension Possible)

Experience: 10+ Years

Job Overview

We are seeking experienced Test Method Validation (TMV) Subject Matter Experts to lead and support TMV execution activities for complex medical device validation projects. This is a senior-level role requiring extensive experience in test method validation, technical leadership, and mentoring validation teams. Candidates should have a strong background in software and hardware validation within regulated environments.

Key Responsibilities

Lead and oversee TMV test execution activities for medical device validation projects.

Provide technical guidance and mentorship to validation engineers during protocol execution.

Review and support the development of TMV protocols, test methods, and acceptance criteria.

Ensure validation activities comply with design controls, quality standards, and regulatory requirements.

Monitor software and hardware validation testing, resolve execution issues, and ensure accurate documentation.

Collaborate with cross-functional engineering and quality teams to support successful project execution.

Required Qualifications

Bachelor's degree in Engineering or a related technical discipline.

10+ years of U.S. experience as a TMV Lead, SME, Coach, or Validation Supervisor .

Hands-on experience executing Test Method Validation (TMV) test cases.

Strong background in software and hardware validation within the medical device industry.

Excellent leadership, mentoring, and technical problem-solving skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com