Project Engineer Clean Utilities

Arcadis; Puurs-Sint-Amands; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Arcadis is seeking a Project Engineer Clean Utilities to lead conceptual, basic and detailed engineering for pharmaceutical clean utilities. You will design and specify systems, coordinate with internal customers, and ensure cGMP compliance across the project lifecycle.

Responsibilities include developing PFDs/P&IDs, creating 3-D models and isometrics, and guiding a design team through construction and validation, with close collaboration across disciplines such as HVAC and electrical.

Qualifications

• Master's degree in civil, industrial, or bio-engineering or equivalent.
• Experience in clean utilities within the pharmaceutical sector.
• Experience with formulation/preparation and validations is a plus.

Responsabilités

• Lead design team to produce 3-D model, piping layouts, views and isometrics for construction.
• Specify systems and equipment, develop PFDs and P&IDs and perform capacity calculations.
• Ensure cGMP compliance and supervise start-up and validation of systems.
• Coordinate with HVAC and electrical disciplines and with other departments.

Connaissances

Clean utilities

3-D model

PFD & P&ID

Team leadership

Regulatory compliance

Process equipment selection

Formation

Master's degree in civil/industrial/biomedical or equivalent

Outils

3D modeling

PFD/P&ID design

Description du poste

As a Project Engineer Clean Utilities you will be responsible for the conceptual, basic, and detailed engineering of clean utilities projects within the pharmaceutical industry. This capability involves providing a clear scope description and design in accordance with standards and coordinated with internal customers.

Key activities include:

• Support engineering, design and execution supervision of Clean utilities distribution systems, Clean utilities generation equipment, Autoclaves, Parts washers and process equipment (sterile vessels, bioreactors, centrifuge systems, UF systems ...) including CIP and SIP. It is your task to evaluate the different alternatives for these systems and the equipment
• You will specify the most appropriate systems and equipment for the user requirements, propose the process flow diagrams (PFD's) and the process & instrumentation diagrams (P&ID's) and make the capacity calculations
• You will develop the functionality (descriptive note and functional specification), the interconnection diagrams and specify the appropriate instruments and regulation loops
• You will assist in completing alarm lists, datasheets and other detailed design documents. Reviewing alarm settings will also be part of your responsibilities
• You will lead a design team to produce the 3-D model, piping layouts, views and isometrics for construction. The spatial co-ordination with other disciplines such as HVAC (ducting) and electricity (cable trays and location of cabinets) will also fall within the scope of your responsibilities. At the end of the detailed engineering phase you will submit tender specifications
• You will assure that the client's specifications and cGMP are respected throughout the entire project. You will organise and follow the start-up of these systems and assure their validation. Site supervision will be performed by the project Site Supervisor
• All these activities will be carried out in a multi-disciplinary engineering team and involve close cooperation with several departments

Profile:

• Master's degree as a civil, industrial, or bio-engineer, industrial pharmacist, or equivalent by experience, often in a scientific field such as Biochemistry or Biotechnology
• Possess experience in clean utilities within the pharmaceutical sector
• Experience with formulation/preparation and having also carried out validations are considered a plus
• Delivery of advanced and autonomous services within a defined scope
• Execution of strategic initiatives, resolution of complex issues, development of innovative solutions, and guidance of technical direction
• Encompass coordination of other resources (team management) and facilitation of knowledge transfer within service parameters