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Dorado, PR, US
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Job Title: Validation Engineer
Job Function: Validate high technology equipment (laser), etc.
Job Type: Full Time 9 months Contract
Location: Dorado, PR (On-Site)

About RCM:
RCM IT & Life Sciences is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.

Scope of Job

RCM is looking for Validation Engineers for our medical technology company client.

Primary Responsibilities
  • Generate & execute protocols; IQ, OQ, PQ.
  • Generate and execute equipment/software validation protocols (IQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
  • Conduct process equipment installation/operational/performance qualification studies to test their functionality.
  • Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
  • Identify and evaluate equipment enhancements to support intended qualified operational ranges.
  • Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
  • Support process capability and statistical analysis related to equipment performance.
Qualifications:
  • Experience with Process validation (IQ/SQ, PC, TMVs)
  • Experience with Process development
  • Experience with Medical Device documentation
  • Experience with Microsoft Office Suite.
  • Highly capable of developing, executing, and reviewing validation life cycle protocols.
  • Knowledge of validation principles, standard concepts, practices, procedures, and requirements in GMP regulated environments.
  • Experience with validation and working knowledge of production is a plus.
Education & Certifications
  • Bachelor's Degree in Engineering with ttwo (2) years of exposure in Process Validation and Development within the Medical Device Industry.
Equal Opportunity Statement
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

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Last updated on Sep 14, 2023

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