Test Method Validation Specialist

2 weeks ago


Danvers, Massachusetts, United States HCLTech Full time

About HCLTech: HCLTech is a leading global technology organization, employing over 223,400 professionals across 60 countries. We specialize in delivering exceptional capabilities in digital transformation, engineering, cloud solutions, and artificial intelligence, supported by a comprehensive range of technology services and products. Our collaborations span various sectors, including Financial Services, Manufacturing, Life Sciences, Healthcare, Technology and Services, Telecom and Media, Retail and Consumer Packaged Goods, and Public Services.

Position Overview:

  • As a Test Method Validation Specialist, you will execute testing procedures in accordance with established guidelines (FDA, SOPs, Work Instructions).
  • Lead efforts in process validation, ensuring that manufacturing processes comply with SOPs and adhere to industry best practices.
  • Design and implement tests to confirm product requirements and specifications, including analyzing historical test data.
  • Responsible for creating and developing test plans, protocols, and comprehensive test reports.
  • Plan and execute test method validations effectively.
  • Authorize validation protocols and reports, ensuring compliance and accuracy.
  • Engage with vendors and may require travel to finalize validation specifications.

Qualifications:

  • A Bachelor's or Master's degree in natural sciences or engineering with a technical focus, or equivalent laboratory experience.

Experience Requirements:

  • Practical experience in test method validation within a laboratory setting.
  • Knowledge of medical device verification and validation processes (minimum of 5 years).
  • Familiarity with electrical and mechanical systems, along with experience in conducting tests.
  • Proficient in statistical analysis and relevant software applications (e.g., Minitab).
  • Experience with documentation practices and compliance with GLP, GDP, and QMS standards.
  • Skilled in statistical tools and methodologies for process optimization and control (IQ, OQ, PQ, PPQ, TMV, Gauge RR, Cpk, SPC).
  • Strong communication, interpersonal, and problem-solving abilities.


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