What are the responsibilities and job description for the Test Method Validation specalist position at TekOne IT Services Pvt. Ltd.?
Key Responsibilities
- Test Requirements Development:
- Derive test requirements from specifications.
- Define test plans and methodologies.
- Estimate efforts and resources for design verification and validation campaigns.
- Establish acceptance criteria and assess through modeling or qualitative/quantitative testing.
- Test Protocol and Execution:
- Write test protocols and set up design experiments.
- Execute tests, analyze results, and document reports with a focus on quality and compliance.
- Mitigate technical risks and resolve issues, ensuring timely project delivery.
- Validation Activities:
- Perform Test Method Validation and Equipment Qualification.
- Lead root cause analysis and investigations on test failures during verification and validation activities.
- Guideline Development:
- Develop best practice guidelines for disposable kit verification and validation.
- Organize standardization and harmonization within the Disposables & Materials Engineering Team.
- Experience:
- Minimum of 7 years in verification and validation processes, particularly in new part development for plastic disposable kit products in regulated industries (preferably medical devices, Class II/III).
- Education:
- Master’s degree or equivalent experience in engineering or scientific fields (mechanics, micro-mechanics, materials).
- Regulatory Knowledge:
- In-depth knowledge of relevant regulations (ISO 13485, FDA 21 CFR Part 820) for US and European market product submissions.
- V&V Management:
- Proven experience in defining and managing verification and validation plans, executing tests, analyzing results, and risk mitigation.
- Manufacturing Processes:
- Experience with V&V activities related to disposable kits and manufacturing processes such as injection molding, compression molding, and more.
- Technical Expertise:
- Hands-on experience with test method validation techniques (DOE, OQ, Gage R&R), mechanical testing (pull/peel, burst, leak tests), packaging design, and stability studies.
- Skills:
- Strong organizational and communication skills in a multidisciplinary, multicultural environment.
- Fluent in written and spoken English.
- Self-starter with creative problem-solving abilities, capable of managing conflicting requirements and technical risks.
