My client is a renowned Biotech in Belgium who are currently searching for several Engineers (CQV; Process; Utilities) to support on-going projects and expansion to existing plants. They are a fast-paced, innovative company, and look for dynamic people who can enjoy the ride with them! Right now, they urgently need a Lead Process Engineer to support the teams in achieving their project goals.
As Lead process engineer you are responsible for the successful execution of projects from A to Z and work closely together with internal stakeholders and suppliers.
Main task will be to lead the Process Systems Stream for an extension of an existing line. Project is currently finalizing Detailed Design with construction starting. You will be responsible to take the project to end of qualification and handover to production.
- 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 while complying with project objectives, 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 analyses (HAZOP, FMEA), 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.
- Knowledge and experience in Biologics or proteins manufacturing environment is a strong plus, including process vessels, filtration, centrifugation, and CIP.
- 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 in designing Pharmaceutical process engineering.
- Experience in Pharmaceutical manufacturing, process validation, equipment qualification
- Experience with Process equipment & piping.
- You speak and write fluent English, Dutch and/or French
- Start date: ASAP.
- Contract duration: Till end of 2022 with option for extension.
- Project/Mission duration: Till end 2022.
- Type of project(s): New production line extension & improvement projects.