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Jobs or company...
F

Validation Engineer

Salary undisclosed

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Dice

Availability Status

This job is expected to be in high demand and may close soon. We’ll remove this job ad once it's closed.

Original
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Job Description

Job Description
Fremont, CA
Contract Duration: 3-24 months
Rate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Validation Engineer in the Fremont, CA area.
  • Manage and participate actively in all phases of qualification/validation for QC systems such as QC analytical instrument and equipment: commissioning/qualification, protocol execution, requalification, and decommissioning/retirement.
  • Provide guidance and technical information to stakeholders/customers
  • Schedule activities and meetings with stakeholders/customers (e.g., to ensure timelines and milestones are on target, resolve/address reviewer comments on deliverables)
  • Perform commissioning and qualification (e.g., oversight/support of vendor qualification, compile
  • Turn Over Package (TOP))
  • Collaborate with vendor and internal maintenance and metrology departments for system onboarding and to establish calibration/maintenance plans (CAL/PM)
  • Generate/author system lifecycle documents (e.g., URS, CS, RA, Protocol, Report) and drive to approvals
  • Execute qualification activities and analyze resultant data
  • Author, review, and resolve execution discrepancies
  • Generate/author/revise standard operating procedures (SOPs)
  • Update validation inventory list
  • Support/provide guidance on QC system's
  • Data Integrity gap assessments/data process maps; Review qualification/validation packages
  • Support and/or assist with thermal mapping activities (e.g., for QC Controlled Temperature Units (TCU) such as freezers)
  • Track completion of Change Control actions
  • Archive and/or scan paper-based execution packages for archival
  • Participate and lead meetings with stakeholders/customers
  • Collaborate with customers (e.g., System Owners/Data Owners) and stakeholders (e.g., QA) to drive validation deliverables (including change control actions) to completion and GxP release of QC systems.

Experience:

  • Bachelor's Degree and 1-2 years of related experience.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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