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 provide top-tier capabilities in digital transformation, engineering, cloud solutions, and artificial intelligence, supported by a comprehensive range of technology services and products. Our collaboration spans various industries, including Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and Consumer Packaged Goods, and Public Services.

Position Overview:

  • In the role of Test Method Validation Specialist, you will execute testing protocols in accordance with established guidelines (FDA, SOPs, Work Instructions).
  • You will spearhead process validation initiatives, ensuring that manufacturing workflows comply with SOPs and adhere to industry best practices.
  • Your responsibilities will include the design and execution of tests to confirm product requirements and specifications, along with analyzing historical test data.
  • You will be tasked with creating and developing test plans, protocols, and comprehensive test reports.
  • Planning and implementing test method validations will be a key part of your role.
  • You will also be responsible for approving validation protocols and reports.
  • Engagement with vendors and potential travel may be required to finalize validation criteria.

Qualifications:

  • A Bachelor’s or Master’s degree in natural sciences or engineering with a technical emphasis, or equivalent laboratory experience as a technician.

Experience Required:

  • A minimum of five years of hands-on experience in test method validation within a laboratory setting.
  • Proficient knowledge of medical device verification and validation processes.
  • Familiarity with electrical and mechanical systems, along with practical experience in conducting tests.
  • Experience with statistical analysis and relevant software applications (e.g., Minitab).
  • Proficient in documentation practices and familiar with GLP, GDP, and QMS standards.
  • Experience utilizing 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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