Clean & Black Utilities Process Engineer
Our client, who works with leading pharmaceutical organisations to support them with the development, processing and manufacturing of protein therapies are currently seeking the expertise of a Clean & Black Utilities Engineer.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- 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.
- In terms of 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. You ensure a clear division of tasks within the team and you follow the project management system for this.
- In addition, you build up the necessary technical knowledge and bring innovative ideas to keep improving.
- You ensure a transparent, fluent and effective communication with all internal stakeholders as well as with external partners (suppliers, contractors, engineering companies, etc.).
- The projects are varied, going from process/productivity improvement to quality or safety improvement, modification of existing production lines
- Engineering master degree, preference Electro-mechanics (Ing./Ir.)
- 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, …) 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.
- Able to multitask and know how to set priorities
- Hands-on mentality and eagerness to perform tests
- Talent for writing clear and complete documents
- Strong planning skills
- Strong communication skills
- Strong organizational skills
- Team player and team coach versed in different disciplines
- Analytical and structural attitude
- Problem solving ability with a broad area of interest
- You speak and write fluent English, Dutch and/or French
Due to covid restrictions we are ideally looking for a candidate based in Belgium, if this is of interest to you then please apply today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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