Validation Engineer

4 weeks ago

Fremont, United States Fladger Assoc. Inc. Full time

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.

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