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
Cmms Engineer Iii
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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