Validation Engineer

4 weeks ago

Fremont, United States Fladger Assoc. Inc. Full time
Job DescriptionJob DescriptionFremont, CAContract Duration: 3-24 monthsRate: 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.

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