- Business Partner Manufacturing
2017 - maintenant
Business partner manufacturing for Ferring Pharmaceuticals, a research driven biopharmaceutical company in the fields of reproductive health, urology, gastroenterology, endocrinology and osteoarthritis..
I am the single point of contact for a Business Domain, and my role consists of the following:
-Deliver or contribute on demand to Business Domain strategy, business cases, strategic IT projects and advise on strategic IT opportunities.
-Be accountable for co-developing and implementing Business Domain strategic domain IT road maps and related domain architectures.
-Be accountable for managing Business Domain demand, i.e. ensuring that demands are aligned with competence center capacity plans, budgets and well settled in the project portfolio.
-Ensure assessment of Business Domain change impact of new strategic solutions as a result of those projects on business accountability.
-Ensure alignment of all Corporate IS team communication to Business Domain leaders and be “in the loop”.
-Ensure and promote consistent Business Domain focus through Corporate IS Competence Center service portfolio.
-Liaise with Business Domain on all relevant Corporate IS services and developing partnership through collaboration.
-Follow up on Business Domain complaints, management escalations and crisis management with the management.
- Manager Solution Architect - Manufacturing Operations Shop Floor - Track and Trace
2016 - 2017
Manager Solution Architect of Manufacturing Operations Shop Floor for Ferring a research driven biopharmaceutical company in the fields of reproductive health, urology, gastroenterology, endocrinology and osteoarthritis.
My role is to design IT solutions at corporate level for the manufacturing operation and especially the integration of the track and trace in the overall company.
I am making the link between the business and the IT world to understand and design solutions that will answer to their needs.
My main activities are:
-Refine URS from business
-Define necessary customisations
-Design integration with the ERP (Oracle) and other systems
-Follow issues and adjust the design during the project phase
-Ensuring documentation quality met pharmaceutical standards
-Manage enhancement process with the business
-Coordinate activities of the support team
-Maintain a road map vision of the systems I am in charge of
-Create a network in the track and trace world
-Stay aware of the software evolutions
- General Manager
2015 - maintenant
General manager for SoftWork Technology, company dedicated to IT and Automation in supplying services and test benches for all the industry.
Building test bench
A specific pharmaceutical expertise around the GxP is completely integrated in all our activities.
My activities are the following:
-Identify and develop sources of potential clients
- Serialisation and Aggregation Project Manager Consultant
2014 - 2016
Serialisation and aggregation project manager consultant for Ferring, a research-driven biopharmaceutical company in the fields of reproductive health, urology, gastroenterology, endocrinology and osteoarthritis.
My role was to organise and coordinate the necessary activities to bring 9 packaging lines into new upcoming serialisation and aggregation requirement which have an impact on all the layers of the software company Automation, MES and ERP:
-Report progress to managers
-Gathering requirement to write the URS
-Define a deployment strategy based on business needs and tactical choice on upcoming regulations
-Managing a 3MF budget to supply mechanical, electrical, hardware, software, installation, commissioning and validation
-Leading a team of 6 engineers
-Producing weekly reports, risks analysis
-Validating project documentation : functional specification, room layout, mechanical and electrical design and batch reports specification
-Validating deliverables (VP, RA, TM, DQ/IQ/OQ/PQ, reports)
-Organising SOP modifications and training activities
- Computerized System Validation Specialist Consultant
2013 - 2013
CSV specialist consultant for UCB, a global biopharma company focusing on severe diseases.
My role was to follow the automation system of a new facility and especially:
-Emerson QA supervision
-SAT protocols checking and reports approval
-Change control impact assessment
- Switzerland Manager
2013 - 2016
Switzerland Manager for PharmaSys, consulting company dedicated to engineering, quality and GxP compliance of computerized and automated systems for health regulated companies.
Regulatory expertise : BPF, BPC, BPL, GxP’s, 21 CFR Part 11, Part 210, 211, 820, CE Marking, ISO 13485 …
Methodological expertise : project lifecycle control, ICH Q9, ICHQ 10, ASTM E2500, GAMP 5
Functional/Technical expertise in :
-Computerized systems (clinical trials, Pharmacovigilance, regulatory affaires, ERP, CAPM, WMS, LIMS, EDM …)
-Automation systems (PLC, SCADA, DCS ...)
-Equipments (production, conditionning, laboratory …)
My activities are the following:
- Automation Project Manager
2012 - 2013
Automation project manager for Boccard Health and Beauty, French company specialized in supplying turnkey solutions for the pharmaceutical industry.
SUPPLY OF PLASMA FRACTIONING FACILTY (BRAZIL):
My role was to manage a team of 10 people and a 2M€ budget. Our scope of supply included the electrical and automation system (cabling, PLC programming, SCADA programming, and the commissioning). The focus was on the qualification/validation required by the pharmaceutical industry and process traceability.
-Team and client management by means of reports and schedules
-Risks, budget, and changes follow-up
SUPPLY OF A FERMENTER FACILITY (MALAYSIA):
My role was to quote this project:
-Analysing the client’s needs
-Establishing a technical specification
-Comparing subcontractor offers
- Automation Project Manager
2010 - 2011
Industrial project manager for Integrated Automation, Australian company based in Victoria and specialized in supplying automation custom solutions.
My role was to manage a team of 10 people and a $500K budget.
-Scope of supply clarification
-Quality gates and budget
-Claim management strategy
EXPLOSIVE COMPOUND FACILITY REVAMPING:
My role was to manage subcontractors and a $100K budget:
-Finding technical solution to minimize the shutdown time.
-Contractors commissioning progress follow-up.
AUTOMATION SUPPLY OF A BIOSOLID RETREATMENT PLANT:
My role was to manage a team of 3 commissioners. The focus was on developing a partnership with the customer by bringing long-term technical solutions. His goal was to maximize investment returns in 30 years.
- Automation Project Manager Consultant
2006 - 2010
Automation project manager for Siemens VAI Metals Technologies, company specialized in the supply of iron and steel industry equipment. The aim was to carry out the management of 20 people in multiple projects on the electrical/automation part of the heavy leveller product with a 12M€ budget. The main phases were:
-Analyse the project technical specification, project risks and deviation
-Split the budget into detail element
-Lead the necessary conception meeting with internal/external people
-Lead internal team and manage their working load in between all the projects (around 14 persons)
-Validate different steps of the conception/test phase for clients (Austria, South Korea, China, Mexico and Thailand) and partners (U.K., Germany and U.S.)
-Foresee the budget and commissioning time until signature of the final acceptance certificate
- Automation Engineer Consultant
2004 - 2010
Automation engineer consultant for Siemens.
- Automation Project Engineer Consultant
2004 - 2006
Automation project engineer for Siemens VAI Metals Technologies. The purpose was to carry out the engineering/tests/commissioning phases on various projects.
ENGINEERING AND COMMISSIONING:
-Writing functional description
-Programming and tests
-8 months commissioning in China.
-Tests supervisor of a heavy downcoiler for Arcelor Mittal in France
-Supervisor of the engineering and commissioning phases of a downcoiler in China.
- Automation Project Engineer
2003 - 2004
Research and development automation engineer for SERT Metal, French company specialized in mould level control for slab casting. The objective was to realize a position sensor in the slab casting environment.
The principle was to make a sensor using the 3D geometry by the triangulation of a laser and a CCD camera.