Andrea D'Alessandro
Frosinone
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
8
8
years of professional experience
Work History
Validation Technician
S.T.B Valitech S.R.L
01.2020 - Current
- Execution of Qualification Test (IQ, OQ and PQ) on equipment such as: Refrigerators, Freezers or climatic chambers
- HVAC System Qualification Autoclave, depyrogenation Tunnel, filling, stoppering and capping machine
- PQ of Freeze dryer, CIP and SIP of tanks and process vessels
- Execution Annual Requalification of Equipment Instrument calibration of Equipment Drafting qualification protocols (IQ, OQ and PQ) Review and drafting of the final Validation Reports/Summary Management of validation tools such as: Kaye Validator, Ellab Val Probe, Testo Data Logger for thermal mapping test Climate, Met-one and Anemometer for HVAC IRTD for calibration Validation instrument Acquired Technical Skills: Validation planning, Teamwork, Qualification and Validation testing, compliance and data integrity knowledge, Software and data analysis Tools skills, Troubleshooting skills.
Validation Technician
Roal Impianti S.r.l
08.2016 - 09.2019
- -Execution of Qualification Test (IQ, OQ and PQ) on equipment such as: Refrigerators, Freezers or climatic chambers
- HVAC System Qualification Autoclave, depyrogenation Tunnel, filling, stoppering and capping machine
- PQ of Freeze dryer, CIP and SIP of tanks and process vessels
- Execution Annual Re-qualification of Equipment Review and drafting of the final Validation Reports/Summary Instrument calibration of Equipment Drafting qualification protocols (IQ, OQ and PQ) Management of validation tools such as: Kaye Validator, Ellab Val Probe, Testo Data Logger for thermal mapping test Climate, Met-one and Anemometer for HVAC IRTD for calibration Validation instrument Acquired Technical Skills: Time management in order to priority, Validation instrument management, compliance and data integrity knowledge, Troubleshooting skills.
Education
Secondary school Diploma -
Istituto Tecnico Professionale “L.Angeloni”
Frosinone12.2014
Skills
- Understanding of Validation Principles: Comprehensive knowledge of validation principles, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)
- Instrument and Measurement: Proficiency in using a variety of instruments and measurement tools to collect accurate data during validation processes This may include: Temperature and thermohygrometric probes, Flow meters, Data logger (Kaye Validator, Ellab val probe)
- Documentation and Record-Keeping: Able to create, maintain, and review validation documentation such as validation protocols, reports, and standard operating procedures (SOPs)
- Data Analysis: Skills in data analysis and interpretation to assess the results of validation tests accurately Export Raw data to excel, trend identification, and comparison against predetermined acceptance criteria
- Regulatory Compliance: Good knowledge of standards and guidelines relevant to the industry, such GMP (Good Manufacturing Practices) and ISO standards
- Process Understanding: Strong understanding of manufacturing processes, equipment operation, and system functionalities to effectively plan and execute validation activities
- Troubleshooting Skills: Able to troubleshoot technical issues encountered during validation testing and recommend appropriate corrective actions to ensure compliance and system functionality
Sector
Chemical and Pharmaceutical industry
Languages
English
Italian
Certifications And Methodological Skills
- Validation Planning
- Execution of Validation Studies
- Data integrity
- Compliance Management
- Qualification and Validation Testing
- Documentation and Reporting
- Training and Education
Years Of Experience
8 years
Personal Information
Title: Validation Technician
Timeline
Validation Technician
S.T.B Valitech S.R.L
01.2020 - Current
Validation Technician
Roal Impianti S.r.l
08.2016 - 09.2019
Secondary school Diploma -
Istituto Tecnico Professionale “L.Angeloni”
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