This biotech client develops projects starting from project definition and scope up to and including start-up in production, after which the new installations are handed over to production & maintenance. They are in need of a Senior Process Engineer (Utilities) to join their team ASAP!
Being part of the Engineering team means being central within the organisation and having a high exposure; from the work floor to the site leadership team!
Start Date: ASAP - end of year. Must be freelancer.
- As a process engineer you are responsible for the successful execution of projects (Clean & Black utilities) from A to Z and work closely with internal stakeholders and suppliers.
- From the start of the project you provide a clear description of the installation in consultation with internal customers (production, maintenance, QA, EHS, etc.). You translate these customer expectations into specifications for further project development.
- Process Engineering: you are responsible for basic and detailed design for clean & black utilities projects complying with project objectives and site specifications and requirements.
- You are able to draw up a detailed planning that is in line with the general project planning, and you ensure timely delivery of the projects within budget, communicating the warnings and deviations to the management team.
- You coordinate purchasing activities (equipment & services) by writing complete RFQ’s and tender books (contractor management).
- You perform the necessary risk analysis and you provide correct documentation.
- You coordinate and supervise the installation of the equipment and you also carry out the verification / qualification / validation tests of the equipment.
- After that you ensure a complete as-built file and handover of the project to the internal customers production and maintenance.
- You are able to lead projects yourself and manage a (multidisciplinary) cross-departmental project team.
- Engineering master degree, preference Electro-mechanics
- Knowledge of project management systems and tools (eg MS Office, MS Project)
- Experience developing projects in a production environment
- Knowledge of cGMP procedures, EMA/FDA requirements & risk management tools HAZOP/FMEA
- Experience with engineering documentation (Energy-Mass balance, P&ID, functional specifications etc) and qualification documents.
- Experience in designing Pharmaceutical process engineering
- Specialized in Clean & Black Utilities.
- Experience in Pharmaceutical manufacturing, process validation, equipment qualification
- Experience with Process equipment, clean utilities and/or black utilities.
- You speak and write fluent English AND Dutch OR French
You must be located in Belgium and able to work both on/off site.
Send your CV to firstname.lastname@example.org to discuss further!