Summary
Overview
Work History
Education
Driver License
Languages
Timeline
Generic
JIMMY LISCIANDRA

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

8
8
years of professional experience

Work History

Project Coordinator - Automation / Process Control

RealDev
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
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
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
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

Driver License

B

Languages

French
Bilingual or Proficient (C2)
English
Advanced (C1)
Espagnol
Intermediate (B1)

Timeline

Project Coordinator - Automation / Process Control

RealDev
11.2023 - Current

Project Leader / Process Engineer

UCB
07.2021 - 06.2023

CQV Engineer - Process Equipment & CSV

Takeda
05.2018 - 06.2021

Product & Process Engineer

GSK
02.2017 - 03.2018

Certificate -

PRINCE2 Foundation

Ecole De Biologie Industrielle
JIMMY LISCIANDRA