Technical environment
Examples of projects
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
Standards
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
Air
Industrial Cooling
Gases
Standards
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
Material
Tools
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
Suppliers
Software
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
Analyzers
Valves
Norms and Regulations
Tools
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
Specific Equipment
Piping
Software
Responsabilities
Management, calculations and monitoring of
Mechanical design – CAD
Supervision of the preparation of
Constraints
Management of external designers or engineers
Technical environment
Pharmaceutical standards – Fine chemistry
Medical Device Standards
Cosmetic Standards
Responsabilities
Product Development / Process
Project management
Technical environment
Tools
Instrumentation
Responsabilities
Production
Continuous improvement
Technical environment
Norms – Pharmacy – Fine Chemistry
Medical Device Standards
Cosmetic Standards
Tools and Standards
Responsabilities
Operational Quality Assurance
Quality System & Management (QMS)
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
Quality Control Analyses
Technical environment
Qualification
Equipment
Facilities
Utilities
Validation
Standards
Responsabilities
Commissioning – Qualification / Validation
Organization
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
Regulatory Maintenance
Technical environment
Pharmacy – Fine Chemistry Standards
Medical Device Standards
Cosmetic Standards
Tools and Methodologies
Responsabilities
Clinical Studies
Clinical Quality Assurance
Biostatistics / Biometrics (data management, statistical analysis, etc.)
Technical environment
Codes and standards
Software
Regulatory Agencies
Responsabilities
PV case management
Database management
PSUR / DSUR writing
SDEA management
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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