Organisation
The company is part of a group and is responsible for packaging and labelling pharmaceuticals. The company has +/- 250 employees. There are also branches in the United Kingdom, the Netherlands and the United States.
The role:
Specification, assurance and improvement of existing and new processes, machines and projects.
* Realisation of projects and process improvements within the set budgets.
* Elaboration of feasibility studies for investments and introduction of new technologies.
* Supporting the development of validation protocols.
* Implementation of validation protocols, in consultation with the quality department.
* Providing technical training and instructions to the production, technical and quality staff.
* Creation of quotation requests, ordering and follow-up of these in the ERP system, checking and approval of invoices.
* Participating in calculation requests and proposing alternative solutions in consultation with the other engineers, project coordinators and the manager.
* Technical and practical coordination and process optimisation of the assigned packaging lines and promoting further development and efficient operation of those lines, in cooperation with the other engineers.
* Development of operational parameters (line speed, performance, changeover times, etc.) and follow-up and adjustment of this process in order to achieve the predefined standards.
* Problem analysis with elaboration of improvement actions, in cooperation with the other engineers.
* Documenting the (new) processes by means of process descriptions, URSs, FAT/SAT, set-up instructions, operating instructions, preventive maintenance instructions, fault analysis schedules, training schedules, validations and others.
* Maintaining contact with suppliers regarding new machines/installations, technical information or interventions, in consultation with the manager.
* Attending trade fairs and training courses with the aim of expanding and optimising technical knowledge of machines and processes.
* Supervising and monitoring hired staff.
* Elaborating, following up and keeping up to date project plans and project budgets and their status, from A to Z
* Actively participate in a continuous improvement process.
* Taking appropriate action (correcting, informing, shutting down machines, etc.) in the event of deviating quality or incorrect functioning of the safety equipment.
* Apply the quality systems regarding Change Requests and CAPAs (Provide support to the quality department in defining CAPAs, translate these CAPAs into actions, implement these actions and follow up).
* Correctly applying and enforcing the safety, hygiene and quality procedures and instructions, with extensive attention to an efficient policy.
* Promoting a good working atmosphere, quality awareness, customer orientation, flexibility, speed, decisiveness and order and cleanliness
Profile
* Bachelor or Master degree obtained in a technical field such as e.g. electromechanics or equivalent through experience.
* Familiar with or interested in GMP guidelines, pharmaceutical guidelines, hygiene, etc.
* Experience with quality systems, procedures, training, etc.
* Very good knowledge of English (written and spoken) Knowledge of Dutch, German or French is an advantage.
* Experience in report writing.
* Conceptual thinking with sound (including technical) knowledge of and experience in project management.
* Strong analytical skills with a solution-oriented attitude.
* Strong in planning and organising, with good cost awareness.
* Good at time management.
* Can work in a result-oriented way with an eye for quality.
* Communicates fluently, both orally and in writing.
* Driven personality with a positive, constructive and "open minded" attitude.
* Can organise work independently and set the right priorities, as well as work in a team.
Offer
* Permanent contract of unlimited duration.
* Working within a strongly growing company.
* Attractive salary package with fringe benefits such as meal vouchers, hospitalisation and group insurance, extra ADV days, ...