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Validation Engineer
Validation EngineerOmni Inclusive • Los Angeles, CA, United States
Validation Engineer

Validation Engineer

Omni Inclusive • Los Angeles, CA, United States
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Conceives, plans and executes manufacturing process validations plans and studies.

  • Adhere to the Change Control and Design Control requirements.
  • To create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's
  • Being the lead on the writing and execution of IQ / OQ / PQ protocols.
  • RCH / PCH - Routing in MAP Agile & follow up till release
  • Updating Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD)
  • Preparing protocol & executing Test Method validation (TMV)
  • Validation experience using risk-based approach guidelines, international regulatory requirements, and standards

Quality and Compliance Related Responsibilities

  • Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations
  • Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
  • Education

  • Degree qualified - ideally science or engineering
  • Other further education and work experience may be considered
  • Experience

  • Minimum 3-years' experience of working on manufacturing engineering validation activities
  • Some previous experience in medical device or related regulated industry
  • Experience in project management and project leadership
  • Extensive experience in the preparation of technical documents
  • Proficient in PLM tools & Microsoft Office
  • Personal Attributes

  • Excellent written and oral communication skills
  • Attention to detail
  • Ability to work as a team
  • Manage your own time and workload
  • Excellent organizational skills
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