Benjamin Jeffroy

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Benjamin Jeffroy

Presentation

Presentation

Within the Life Sciences Business Unit, NEO2 develops partnerships with industrialists in the health and cosmetics sector. Established in this sector for more than 10 years, NEO2 knows how to put its technical know-how at the service of its clients and consultants.

Sub-sectors

Medical Devices

  • Class I : Low risk
  • Class II : Low to high risk
  • Class III : High risk
Medical Devices

Pharmaceuticals

  • Pharmaceuticals (Human and Veterinary)
  • Chemistry (APIs / Active Pharmaceutical Ingredients)
  • Biotechnology
Pharmaceuticals

Cosmetics

  • Hygiene
  • Care
  • Makeup
  • Perfume
Cosmetics

Disciplines

Technical environment

  • Process
  • Utilities (hot / cold, purified water, PPE, etc.)
  • Mechanics (piping, equipment, thermal, etc.)
  • Electricity, automation, instrumentation
  • Building, civil engineering, structures
  • Civil Engineering

Examples of projects

  • Creation / renovation / replacement of production lines
  • Industrialization of processes (pilot to semi-industrial and semi-industrial to industrial)
  • Construction / extension of buildings (production, storage, etc.)
  • Line transfer
  • Revamping of supervision and control-command systems
  • Workshop reconfiguration (general layout)
  • Compliance with standards / standards

Responsabilities

Definition of technical needs

Realisation studies APS / APD

Preparation of the planning and budgets

Realisation of the specifications and technical specifications

Consultation of suppliers

Technical alignment of offers

Selection of suppliers and implementation of subcontracting contracts

Monitoring of studies

Reception of equipment on site

Monitoring of work and the site

Commissioning / production

Compliance with safety and HSE plans on site

Technical environment

Process types

  • Fermentation
  • Separation
  • Formulation and Preparation
  • Grinding
  • Drying
  • Mixing
  • Purification and Ultra-Purification
  • Lyophilization
  • Aseptic Filling
  • Visual inspection
  • Primary/Secondary/Tertiary Packaging
  • Cleaning and Sterilization
  • USP / DSP

Standards

  • FDA – cGMP
  • ANSM – BPF
  • ASME BPE
  • ATEX

Responsabilities

Development, Design, and Simulation of Processes

Sizing / Data Sheets

Preparation / Modification of P&IDs and PFDs

Participation in Risk Assessments

Troubleshooting

Participation in HAZOP Reviews

Management of Equipment, Engineering Office, Automation, Instrumentation, and Other Interfaces

Technical environment

Water

  • Purified water
  • Purified Water for Injectable Solutions
  • Steam
  • Etc.

Air

  • Air Handling Units
  • HVAC/CVC
  • Compressed Air
  • Etc.

Industrial Cooling

Gases

  • Nitrogen
  • Oxygen
  • Carbon Dioxide
  • Etc.

Standards

  • FDA – cGMP
  • ANSM – BPF
  • ASME BPE
  • ATEX

Responsabilities

Process design and simulation

Dimensioning / DataSheets

Realisation studies APS / APD

Preparation / modification PID and PFD

Supervision of installation and site

Participation in risk studies

Management of equipment, automation, instrumentation, etc. interfaces

Troubleshooting

Technical environment

Voltage / Current

  • Ultra or Extra HV (300 kV – 1200 kV)
  • HVB (> 52 kV)
  • HVA or MV (1 kV – 52 kV)
  • LV (50 V – 1 kV)
  • High current
  • Low current

Material

  • HV / LV cells
  • Transformers
  • HV / LV substation
  • Main low-voltage switchboard
  • HV / MV circuit breakers
  • Variator / Inverters
  • HV and LV cables
  • Lighting

Tools

  • CANECO HT/BT
  • See Electrical
  • Dialux

Responsabilities

Design of HV / LV single-line diagrams

Realisation of the power balance

Realisation of calculations (HV / LV cables, short circuit levels, etc.)

Realisation of studies (selectivity, stability, harmonics, power factor)

Monitoring of electrical diagrams

Realisation of technical specifications

Contract monitoring

Technical environment

Materials

  • SNCC / DCS
  • API / PLC
  • Instruments (flow, pressure, temperature, etc.)

Suppliers

  • Foxboro
  • Yokogawa
  • Honeywell
  • Schneider Electric
  • Delta V

Software

  • TEC4
  • Toolset
  • Desigo Toolset
  • PL7 PRO
  • Unity
  • Intools
  • Distech
  • Wago

Responsabilities

Design of the control system architecture

Realisation of general specifications

Realisation of the functional analysis and logic diagrams (organic analysis)

Realisation of the list of inputs / outputs

Hardware and software specification

Subcontractor monitoring

Verification of wiring diagrams

Realisation of FAT / SAT

Technical environment

Materials

Sensors

  • Pressure
  • Temperature
  • Level
  • Flow
  • Transmitters

Analyzers

Valves

  • Control
  • On/off
  • Manual
  • Butterfly

Norms and Regulations

  • ATEX, API, etc.

Tools

  • Intools

Responsabilities

Preparation of the instrumentation list

Detailed specification of instruments and datasheets

Creation of detailed assembly diagrams (hook-up)

Creation of standard connection diagrams

Participation in FAT / SAT

Contract monitoring

Technical environment

Main Equipment

  • Turbines
  • Pumps
  • Compressors

Specific Equipment

  • Skids
  • Boilers
  • Furnaces
  • Valves and Fittings
  • Vanes
  • Boilermaking
  • Handling / Lifting

Piping

  • Support

Software

  • PDMS
  • Microstation
  • PDS
  • Autocad 2D / 3D
  • CAD: SolidWorks, Catia, NX

Responsabilities

Management, calculations and monitoring of

  • Fluid
  • Thermal
  • Vibration
  • Structural

Mechanical design – CAD

  • Structural mechanical parts
  • Static and dynamic seals
  • Connecting elements

Supervision of the preparation of

  • General installation plans
  • Structural plans
  • Overall plans
  • Electrical diagrams
  • Process diagrams (PFD and PID)
  • Assembly and support plans
  • Isometrics

Constraints

  • Operations
  • Maintenance
  • Ergonomics
  • Safety

Management of external designers or engineers

Technical environment

Pharmaceutical standards – Fine chemistry

  • BPF / GMP
  • BPL / GLP

Medical Device Standards

  • ISO 13485
  • Directive 93/42/EEC
  • Directive 93/79/CE

Cosmetic Standards

  • ISO 22716
  • ANSM
  • FDA

Responsabilities

Product Development / Process

  • Formulation
  • Galenic development
  • Analytical transfers

Project management

  • Budget, planning
  • Specifications writing
  • Process risk analysis
  • Supplier management
  • Commissioning
  • Scale-Up

Technical environment

Tools

  • MES / ERP
  • 5S
  • SMED
  • 6 Sigma
  • Hoshin
  • Cause & Effect Matrix

Instrumentation

  • Sensors
  • Metrology
  • Signal conditioning
  • Control and command

Responsabilities

Production

  • Implementation and monitoring of the manufacturing and scheduling plan
  • Supply and inventory management
  • Management of production teams
  • Computer-based management of manufacturing processes
  • Productivity monitoring

Continuous improvement

  • Implementation of Kaizen, lean management and TPM
  • Implementation of 6 sigma, 5S, SMED, Hoshin methods
  • Complete mapping of production workshop losses
  • Operator training

Technical environment

Norms – Pharmacy – Fine Chemistry

  • ISO 17025
  • Pharmacopoeias (EU, US)
  • ICH Q7 / Q8 / Q9 / Q10
  • GMP part II – ICH Q7
  • BPF, BPL
  • 21 CFR part 11

Medical Device Standards

  • ISO 13485
  • ISO 9001
  • ISO 14001

Cosmetic Standards

  • ISO 22716
  • BPF, BPL

Tools and Standards

  • MES / ERP
  • AMDEC
  • 5W2H, 5M, FIFO, PDCA

Responsabilities

Operational Quality Assurance

  • Management of CAPA, non-conformities, deviations
  • Change management / quality supplier
  • Impact analysis / investigations
  • Establishment of action plans
  • Analysis / processing / writing Change Control
  • Implementation of quality indicators / customer complaints management

Quality System & Management (QMS)

  • Documentation management (instructions, procedures, etc.)
  • Compliance
  • Audit gap analysis
  • Staff training
  • Preparation of audits (suppliers, FDA)
  • Product Quality Review (PQR)

Technical environment

Pharmacy – Fine Chemistry Standards

GMP, GLP, GDP
ISO Standards
Pharmacopoeias (EU, US)
ICH Q7 / Q8 / Q9 / Q10
GMP Part II – ICH Q7
21 CFR Part 11

Medical Device Standards

ISO 13485
ISO 9001
ISO 14001
MDR

Cosmetic Standards

ISO 22716
GMP, GLP

Tools and Methodologies

MES / ERP
FMEA
5W2H, 5M, FIFO, PDCA

Responsabilities

Skills and Actions

  • Monitoring of quality controls of raw materials, bulk products, finished products and packaging items
  • Analytical control
  • Microbiological control
  • Formulation
  • Writing of certificates of analysis
  • Synthesis of organic molecules

Quality Control Analyses

  • Titration (Volumetric, Gravimetric, Coulometric, Immunometric)
  • Chromatography (HPLC, SFC, GC or LC)
  • Spectrometry (Atomic, Molecular IR, UV-Visible)
  • Fluorimetry
  • Organoleptic
  • Rheology

Technical environment

Qualification

Equipment

  • Formulation
  • Production
  • Washing and Sterilization
  • Packaging

Facilities

  • Clean Room (Class A to D)
  • Controlled Atmosphere Zone
  • Climate Chamber

Utilities

  • Water (PW, HPW, WFI, etc.)
  • Air (AHU, HVAC, AC)
  • Gases (CO2, N2, O2)

Validation

  • Processes (manufacturing, packaging, etc.)
  • Cleaning and Sterilization (manual, semi-automatic, CIP)
  • Analytical Methods
  • Computerized and Automated Systems

Standards

  • GMP Annex 15 – GMP / BPF
  • 21 CFR – FDA
  • ISO 13985 / MDR

Responsabilities

Commissioning – Qualification / Validation

  • URS / QC / QD
  • FAT / SAT
  • IQ / OQ / PQ

Organization

  • Risk Analysis
  • Definition of the Validation Plan
  • Definition and Writing of Protocols
  • Definition and Execution of Tests
  • Definition and Writing of Reports

Technical environment

Pharmaceutical Standards

ISO 9001
GMP
FDA
ANSM
ENVISA

Medical Device Standards

ISO 13485
MDR 2017/745
MDR 2017/746

Cosmetic Standards

ISO 22716
ANSM
FDA
REACH/CLP

Responsabilities

Market Authorization

  • Submission of Marketing Authorization Applications (Compilation of dossiers, submission to authorities)
  • Management of Modules 1 to 5 according to CTD
  • Preparation of Technical Documentation – CE Marking (Compilation of dossiers, writing of reports)
  • Compliance with MDR Standards
  • Preparation of MDR Compliance Dossiers

Regulatory Maintenance

  • Updating of Dossiers
  • Product Risk Analysis
  • Regulatory Monitoring
  • Advertising Control

Technical environment

Pharmacy – Fine Chemistry Standards

  • GMP, GLP, GDP
  • ISO Standards
  • Pharmacopoeias (EU, US)
  • ICH Q7 / Q8 / Q9 / Q10
  • GMP Part II – ICH Q7
  • 21 CFR Part 11

Medical Device Standards

  • ISO 13485
  • ISO 9001
  • ISO 14001
  • MDR

Cosmetic Standards

  • ISO 22716
  • GMP, GLP

Tools and Methodologies

  • MES / ERP
  • FMEA
  • 5W2H, 5M, FIFO, PDCA

Responsabilities

Clinical Studies

  • Coordination and Management of Clinical Studies
  • Support for Clinical Research (CRAs, etc.)
  • Management and Coordination of Subcontractors
  • Publishing

Clinical Quality Assurance

  • Quality Management
  • Training (regulation and conduct of clinical trials)
  • Writing and Reviewing Procedures

Biostatistics / Biometrics (data management, statistical analysis, etc.)

  • Writing Statistical Analysis Plans
  • Reporting

Technical environment

Codes and standards

  • BPV / GVP
  • BPC / GCP
  • BPF / GMP
  • MedDRA

Software

  • ARGUS
  • Safety Easy
  • EudraVigilance

Regulatory Agencies

  • CPP
  • EMA
  • ANSM
  • FDA
  • ICH

Responsabilities

PV case management

  • Case collection and analysis
  • Documentation
  • Registration
  • Evaluation
  • Adverse event reporting

Database management

  • Narrative writing
  • Data reconciliation
  • Duplicate detection

PSUR / DSUR writing

  • Preparation of periodic safety reports (PSURs)
  • Collection and analysis of PV case data
  • Detection of cases of interest

SDEA management

  • Writing and monitoring of Safety Data Exchange Agreements (SDEAs)
  • Writing of monthly PV reports

Projects

Supplier Quality Assurance

Project :

The health sector have the most stringent safety and quality standards due to the direct impact on user health. Therefore, every player in these industries must be impeccable and ensure that its suppliers are as well in order to avoid any risk throughout the chain. This is the goal of the Supplier Quality Assurance missions that NEO2 carries out for its clients.

Description :

For over 4 years, NEO2 has been conducting supplier quality assurance audit projects and focusing its actions on crucial points :

• Manage external audit programs to ensure follow-up of audits and implementation of corrective actions
• Manage AQ Supplier service non-conformities identified by the Notified Body during the previous certification audit
• Update Product Directives (Class 3) files to a new European Regulation 2017/745 in conjunction with the Regulatory department

Lotion Manufacturing Platform

Project :

The cosmetics industry is constantly evolving, with new product ranges being validated and ready to be offered to customers. As each range is different, it is not uncommon for all or part of the manufacturing process to have to be modified or even replaced.

Description :

NEO2 has had the opportunity to work on cosmetic manufacturing processes on several occasions. Since 2021, we have been working on a lotion manufacturing platform implementation project from the preliminary project to commissioning :

• Carry out preliminary studies starting with the Functional Analysis and specifications to be able to then launch calls for tenders
• Qualify equipment in accordance with the specifications (Quality, Ergonomics, Usefulness, etc.) by following and validating the design (P&ID, assembly plan, automaton, etc.)
• Install the platform by planning and supervising the site and testing the design in the supplier's factory (FAT) and then on site (SAT)
• Commission the platform and execute the different qualifications: Installation, Operational and Performance

Quality Control

Project :

The pharmaceutical industry is vital for our society and for each individual making it up. It must therefore be very demanding on quality and safety aspects with dedicated poles and experts.
This is the case of one of our clients whose activity is dedicated to aseptic and steroid active ingredients (API) as well as to the manufacture of sterile injectables.

Description :

NEO2 intervenes with this client to respond to deviations issued by the ANSM following an inspection :

• Implement a computer system allowing the automation of the generation of a trend analysis report
• Manage the project by identifying objectives, carrying out feasibility studies, writing user needs and training staff
• Implement the solution using statistical process control and control charts to monitor out-of-trend results
• Carry out Qualification and Validation by writing the validation plan, traceability matrix and QI/QO/QP protocols

Open Positions

Are you interested in working in the healthcare or cosmetics industry?

NEO2 is constantly looking for new talent to strengthen our teams and support our clients on projects that make sense.

You can directly apply to our offers or send us a spontaneous application.

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