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Validation Engineer - Fremont, United States - Fladger Assoc. Inc.
Description
Job DescriptionJob 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.
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