Amir Valadan

Experienced Metrology & Quality Professional with over 10 years experience serving the Pharmaceutical industry.

Role
Cmms Engineer Iii at Transcat Solutions
Location
San Diego, CA, US
LinkedIn followers
500 followers

Experience

  1. Cmms Engineer Iii

    Transcat Solutions

    Aug 2023 — Present · San Diego, CA, US

    Maintain and oversee asset lifecycle management including design, procure, commissioning, qualification, validation, equipment reliability, upgrading, maintenance, calibration, spare parts, planning and scheduling activities- Maintain and oversee site asset service contracts using Power BI- Coordinate and collaborate with vendors and internal colleagues for timely accomplishment of equipment repairs, relocation, preventative/corrective maintenance, calibration, qualification, onboarding, and retiring- Assisted with migration of current CMMS to Blue Mountain RAM and utilization of Blue Mountain RAM- BMRAM system administrator for multiple sites- Perform quality system functions related to Non-Conforming (OOT) Events, CAPAs, Change Controls, SOP Revisions, Audit Responses, etc, as required- Assist with other continuous improvement and optimization projects, as required- Enter/Review equipment calibration, maintenance, qualification documentation in Veeva document control system - Complete/Coordinate/Review documentation related to equipment changes like remove/return to service, relocation, onboarding and decommissioning- Enter/Obtain Purchase Requisitions / Purchase Orders for asset service contracts, PMs, CALs, Qualifications, repairs, etc. in Oracle ERP- Enter/Obtain asset service agreements in Jaggaer- Meet regularly with all stakeholders to discuss progress, communicate changes, and support the entire change effort- Provide KPI metrics associated with % on-time monthly asset maintenance/calibration/qualifications, as required- Field walk-downs to verify accuracy of equipment data- Carry out all tracking, technical data reviews and entry in the CMMS system- Support the update of calibration/maintenance job plans/aids- Monitor monthly calibration standards schedules and support the shipping of calibration standards to offsite vendors- Review and attach calibration standard certificates to the work order prior to closure/approval

Education

  • University of Phoenix

    Master of Business Administration (MBA)

  • University of Illinois Chicago

    Bachelor's degree

Skills

  • Gmp
  • Fda
  • Sop
  • Quality Control
  • Quality System
  • Medical Devices
  • Laboratory
  • Capa
  • Quality Engineering
  • Quality Assurance
  • Analytical Chemistry
  • Glp
  • Lims
  • Process Improvement
  • Pharmaceutical Industry
  • Manufacturing
  • Sop Development
  • Fda Gmp
  • Laboratory Skills
  • Laboratory Safety
  • Team Building
  • Team Leadership
  • Team Management
  • Team Motivation
  • Teamwork
  • Validation
  • Chemistry
  • Uv/Vis
  • Hplc
  • Wet Chemistry
  • Continuous Improvement
  • Stability Studies
  • Stability Testing
  • General Investigations
  • Root Cause Analysis
  • 5 Why
  • Lean Six Sigma
  • Six Sigma
  • 21 Cfr Part 11
  • 21 Cfr

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Amir Valadan — Cmms Engineer Iii at Transcat Solutions in San Diego, CA, US | Unifers