Summary

Overview

Work History

Education

Driver License

Languages

Timeline

JIMMY LISCIANDRA

Brussels

Summary

Thanks to my various experiences, I have a versatile profile in the pharmaceutical sector. I am looking for a position as CQV expert or process engineer.

Overview

years of professional experience

Work History

Project Coordinator - Automation / Process Control

RealDev

Brussels

11.2023 - Current

Projects management in industrial automation and digitalization, from study to production implementation, including the implementation of technical modifications and user training, with the aim of managing obsolescence, ensuring regulatory compliance, and optimizing production equipment for the pharmaceutical industry (Autoclaves, centrifuges, chromatography, Dry-Fog)
Management of subcontractors for installation or modification activities on GMP equipment (Work permits, operating procedures, LOTO, legal inspection, technical testing, investigation, calibration, maintenance)
Management of the CQV/CSV activities (Writing of protocols, execution of testing, updating of design documents with Kneat, Veeva and SAP)
Project management and tracking documentation update (Reporting, Tracking, KPIs, Planning, Risks & Issues), management of project meetings at different levels (from daily team meetings to sponsor meetings)

Project Leader / Process Engineer

UCB

Braine-l'Alleud

07.2021 - 06.2023

Writing and reviewing the documentation for the implementation of new equipment and processes for the aseptic filling of biological molecules (change control, URS, specifications, risk and impact analysis, FAT/development/validation protocols, reports, SOPs, deviations)
Developement of action plan to increase production capacity and process optimization linked to FDA audit
Task monitoring with different project SMEs and reporting of KPIs (Budget, planning, resource, deliverable, quality)

CQV Engineer - Process Equipment & CSV

Takeda

Lessines

05.2018 - 06.2021

Participation in the commissioning and validation of a new purification/formulation line for biopharmaceutical products (Skid UF/Vessels), and associated cleaning systems (CIP) and automated systems (PCS, SCADA, HMI, EBR)
Validation of cleanrooms and associated HVAC systems, storage areas and industrial freezers
Writing all V cycle documentation: Validation plan, URS, FDS, Design Review, risk analysis, IQ/OQ/PQ protocols, reports, deviations

Product & Process Engineer

GSK

Wavre

02.2017 - 03.2018

Development of a new agitation technology for mobile tank formulation of vaccines (FAT, commissioning, test result analysis)
Writing the documentation associated (URS, test protocols, reports, SOP for user/maintenance)
Management of technical testing and coordination of the project with internal and external stakeholders

Education

Certificate -

PRINCE2 Foundation

01-2021

Ecole De Biologie Industrielle

01-2017