Jonathan Goffinet

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Jonathan Goffinet
Industrial Engineer in Biochemistry (Biopharmaceutical oriented)
  • Residence:
    Belgium
  • City:
    Arquennes
  • Age:
    36
French
English
  • Computerized System Development
  • Computerized System Validation
  • Project Management
  • Business Overview
  • Leadership
  • cGMP
  • Agile
  • Bioprocess Development
  • People Management
  • Django
  • Office 365 Admin
  • DNS
  • Linux
  • nginx

Bring valuable
expertize !




< Value > </ Value >
Photo
13 +
Years Experience
9 +
Years in GMP environment
2 +
Department Creation
10 +
Audits

Professional Experiences

Artelis - Trainee Scientist
Realization of my Master Thesis: "Développement d'un bioprocédé visant la culture, à l'échelle industrielle, de cardiomyoblastes pour une application en thérapie cellulaire" focus on the development of a bioprocess aiming the cardiomyoblast expansion at industrial scale for cell therapy application.

The main objective of the thesis was to:
- Evaluate single-use sensor technology for its application in the large-scale single-use bioreactor.
- Develop cell culture protocol (cell seeding, growth and harvest) in a small-scale prototype bioreactor.
- Evaluate the shear stress profile applied on the cell layer.

Artelis - Junior Scientist
As Junior Scientist, I was focus on the development of a single-use bioreactor dedicated for Cell Therapy Applications.
As Engineer in Biochemistry, my mission was to work with the Automation team and the Cell Culture team in order to translate Cell Culture needs/requirements to technical solution taking into account the constraints highlighted by the Automation team.
In a second time, I also participated to project aiming the production of virus in single-use bioreactor for Vaccine Applications

Artelis / ATMI LF - Applicaion Support
As Application Support, my responsibilities were:
- Listen customer and understand his needs/targets.
- Install and qualify equipment.
- Ensure training of customers.
- Establish an experimental plan in order to transfer the customer's process to our single-use technologies and improve production yield.

This required closed, professional and transparent contact with our customers.
During this mission, I had the opportunity to travel around the world and meet valuable experts in the Cell Therapy and Vaccines fields.

Masthercell - Technical Service Supervisor
I joined Masthercell in 2014 as Technical Service Supervisor to build the Technical Service Department.

My responsibilities were:
- Managing the equipment lifecycle according to cGMP regulation including HVAC systems and Production Room Qualification.
- Managing warehousing and procurement.
- Putting in place SOP to manage all Technical Service responsibilities.

During this mission, I was also involved in additional project such as:
- Scale-out feasibility study in Quantum bioreactors.
- Implementation of ERP system to manage Accounting, Procurement and Inventory.

Masthercell - Development Engineer
2 years later having started my collaboration with Masthercell and thanks to the success of the Quantum project, I was promoted to Project Management Department as Development Engineer in order to promote Development service of the company as CDMO.
My mission was the development of bioprocess that will address the long-term industrialization of the cell therapy in terms of GMP constraints and cost.

Phacilitate's Interview

Masthercell - IT Manager
Following the company growth and thanks to my previous experience, I was promoted to create the IT department of Masthercell.

I put in place SOP compliant with cGMP and Sox regulations to ensure:
- Computerized System Lifecycle (V-approach)
- Access Control Management
- Business continuity and disaster recovery plan

My responsibilities were (not exhaustive list):
- Manage annual budget (OPEX and CAPEX)
- Manage a team of 6 people with different expertise/profile (BI - Developers - Admin System)
- Introduce the concept of Industry 4.0 to the company.

Masthercell / Catalent - Senior IT Manager
After 3 years of successful projects (see My Realization section), I was promoted as Senior IT Manager.

Asdaex - Sr. Project Manager
Managing Automation projects for Pharmaceutical Industry from the quote to the solution delivery.
My current responsibilities are:
- Planning generation according to client deadline and tasks to achieved (GAMP 5 - V-Approach).
- Implement validation strategy according to customer's SOP.
- Risk assessment and management
- Schedule adherence, resources and budget control.
- People relation.
- Technical support for specification, development and computerized system validation

My Realizations

Scale-out feasability study in Quantum
aug-2014

The objective of this project was to highlight the ability of Quantum bioreactor to support scale-out production (up-to 10 systems running in parallel) while keeping low manpower need.

Applied Skills:

  • Tech transfer
  • Project Management
  • Equipment Qualification
  • Experimental plan design
  • Bioprocess optimization
  • Team leader
  • Data analysis & reporting

Production Unit Commissionning
may-2015

The objective of this project was to equip and commission a new production unit to increase manufacturing capacity of Masthercell.

Applied Skills:

  • URS definition
  • Equipment selection
  • Procurement process (including price negotiation)
  • System Qualification/Validation
  • Project Management
  • Budget Control

Odoo ERP Implementation
sep-2015

The objective of the project was to implement Odoo 8 as ERP to replace Paper and Spreadsheet management of Accounting, Inventory and Procurement.

Applied Skills:

  • URS definition
  • Metadata management
  • Process Definition
  • Training
  • Change Control
  • Project Management
  • Budget Control

QMS system implementation
mar-2016

When I started at Masthercell, all processes were managed through paper-based system which have limitation regarding data capture, action follow-up and reporting. Therefore, I convinced the management to invest in a QMS platform such as Verse Solution - ETQ.

Therefore, I was involved in the team in charge of Verse Solution implementation. Deviation, CAPA, OOS and Document Control processes have finally been digitalized.

Applied Skills:

  • URS definition
  • Metadata management
  • Software Validation
  • Training
  • Change Control
  • Project Management

Odoo Hosting migration
feb-2017

Following the ERP implementation project, the decision was taken to migrate the cloud hosting of our ERP platform to on-premises servers in order to:

  • Improve performance and user experience.
  • Manage and ensure the complete lifecycle of the system (development, validation, backup, etc.)

Training System Implementation
jun-2017

After the success of Verse Solution implementation, the management saw the real interest to digitalize the enterprise since it gives better and faster visibility on activities and reduces the risk associated to data corruption and human mistake.

I continued this success rate by developing with our partner and implementing a training management system.

Applied Skills:

  • URS definition
  • Agile Methodology
  • GAMP 5 validation
  • Software development
  • Process Definition
  • Training
  • Change Control
  • Project Management
  • Budget Control

Odoo ERP Refactoring
dec-2017

Because the needs of the company were growing and because processes were evolving due to gain of maturity, we took the opportunity of migrating the ERP from Odoo 8 to Odoo 11 in order to review and improve some processes.

Within 6 months, we succeeded to deliver a complete revised solution integrating additional modules such as leave, timesheet, project, expense, helpdesk without impact on operation activities and with the respect of the deadline linked to the fiscal year.

Accounting process, inventory strategy and management were also refactored

EMS Implementation
may-2018

In the context of continuous improvement, the management asked me to find and implement an alternative solution to the current EMS system to increase the robustness, traceability and ownership.

I lead the implementation of Mirrhia EMS system.

Applied Skills:

  • Industrial Automation
  • Network Architecture
  • Computerized System Definition
  • Computerized System Validation
  • Change Control
  • End-User Experience

Production Facility extension
aug-2018

In 2018, Masthercell invested to extend and double the surface of production area. I was involved in this project to define IT and Industrial requirements and to follow deployment of systems such as:

  • Access Control Management
  • Network Architecture
  • Industrial Network
  • Redundancy

Real Time Cleaning Management
may-2021

Setting up a Real Time Cleaning Management System in AVEVA System Platform SCADA. The scope of this project was designing a solution to:

  • Help cleaning operators to schedule cleaning activities according to the customer's procedures.
  • Record cleaning activities.
  • Generate alerts and alarms when cleaning validity is expired.
  • Generate reports to ease batch release process.
  • Interact with the eBR system and prevent production activities if productions areas are not cleaned.

Equipment Integration in EMS system
oct-2021

Integration of multiple equipment such as freezers, storage room and refrigerator to the customer's Environment Monitoring System.

Applied Skills:

  • GAMP 4 validation
  • Industrial Automation
  • Change Control
  • Project Management
  • Budget Control

Define equipment integration strategy
feb-2022

Qualitative inventory of a vaccine production site to identify equipment used on the process. Identify communication capabilities for each type of equipment. Define equipment category according to their usage, data type and communication capabilities. Generate for each category a standardize approach to integrate equipment in a data acquisition flow (Equipment > SCADA > OSI-PI > eBR).

Basic Design for an Interlocking Management System
dec-2022

Electrical and SCADA study for implementation of an Interlocking Management System

Alarm Management System - Basic Design
feb-2023

Create URS and basic design for an AMS system for a pharmaceutical customer.

Recommendations

Denis Bedoret
Chief Executive Officer at Imcyse SA

« Jonathan is a very talented, pragmatic and effective IT leader. During the time we worked together, Jonathan has consistently demonstrated impressive initiative, drive to get things done, flexibility and commitment to the success of our projects. In addition, Jonathan can quickly grasp any complex issue and has a tremendous ability to balance operational needs with IT development constraints even in a very demanding GMP environment. I would recommend him without hesitation and would certainly welcome any opportunity to work with him again someday in the future »

Eric Mathieu
COO - Masthercell SA

« Jonathan a la tête bien sur les épaules, une conscience professionnelle très appréciée et un degré de qualité et d’implication à toute épreuve. Autodidacte et orienté solutions, sa flexibilité et sa bonne humeur ont été des facteurs clé de notre collaboration de plus de 6 années consécutives à différents positions : la gestion technique, la gestion de projets en culture cellulaire et la mise en œuvre informatique de systèmes validés ou non ainsi que d’outils et de réseaux ont été des francs succès »

Fabien Debras
Cell Culture Operation Manager

« Jonathan is reliable and professional in all circumstances. He is very committed to the client’s satisfaction and has a good spirit of cooperation. I appreciate him as an Application Support and a good-natured colleague. It is definitely a pleasure to work with him »

Articles

A.I.I.F - I.M.C. - Contact
Integrity Xpansion Multiplate Bioreactor Adherent Stem Cell Expansion Poster
Integrity Xpansion Multiplate Bioreactor Microscope Poster ISSCR 2012
Automation of upstream and downstream manufacturing process of cell therapeutic product
Gain yield with reduced manpower by using closed atmi’s XP bio
Scale-up of hepatic progenitor cells from multitray stack to 2-D bioreactors
Transfer of Hepatic Progenitor Stem Cell Culture Process from Multitray Stacks to the Xpansion
New peptide-based and animal-free coatings for animal cell culture in bioreactors
Large Scale Manufacturing Development of Adherent Stem Cells
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