• Strong background within Clean Utilities generation and distribution (e.g. WFI, PW, clean steam, compressed gases, clean compressed air) and other associated equipment’s (COP/SOP, autoclaves, washing machine, buffer preparation and formulation vessels).
• Experience with EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models is mandatory
• Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required, as well as mass & heat balances.
• Ability to lead & review PED (Pressure Equipment Directive) is a mandatory asset
• Ability to act as technical process expert during HSE risk assessment (HAZOP, what if analysis, etc…) / QRA (Quality Risk Analysis) / FMEA
• Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant
• Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
• Experience in large and complex projects as well as both formal and informal leadership / coordination
URS & Technical specifications
• Review the URS provided by the Engineering Office in order to ensure all User requirements are fully respected
• Include all technical requests in the URS for commissioning and qualification.
BASIC & DETAILED DESIGN
• Define the applicable standards/norms/engineering guidelines for the project
• Provide Engineering offices with the applicable standards
• Review PFD and P&ID
• Review Process Simulation related to the discipline from Engineering Office
• Review Mass balance and heat balance related to the discipline from Engineering Office
• Review URS, functional and technical specs and datasheets from Engineering Office
• Review pressure loss calculation from Engineering office
• Challenge technical solutions coming from Engineering office
• Integrate safety, sustainability and green assessment in the design
• Participate to define the reporting (automation/IT) specifications related to the discipline
• Ensure project deliverables of his discipline
• Based on progress report of the construction manager, perform on a regular basis field spot check follow-up
• Organize quality checks on field before each technical milestone activity.
• Communicate the day to day schedule (planning level 4) to the Engineering Leader and construction manager
• Ensure a good communication with other Specialists linked to its activity (Battery limits)
• Maintain his knowledge accuracy based on new technology. Keep up-to-date
• Write down technical specifications related with its area of expertise and provide the document to the engineering Leader for review
• Define battery limit and RACI matrix with Engineering Leader
• Update drawings in its area of expertise
• Write commissioning documentation and ensure that the supplier’s documentation is acceptable to perform verification (ASTM 2500)
• Perform FAT/SAT activities in its area of expertise if needed
• Support the qualification phases after commissioning (V-Cycle and/or ASTM2500)
• Organize the training of the final user in its area of expertise & provide technical documentation in to finalize the Hand-over
• Actively perfom the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist
• Respect documentation strategy
HSE & Green
• Ensure compliance to HSE & Green requirements and rules
• Ensure the 3 green lights are scheduled and correctly organized
Minimum 15 years of experience within pharmaceutical companies and working with Engineering offices