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Sr Engineer - Engineering

Job title:  Senior Project Engineer Clean & Black Utilities

Reports to the Supervisor Process Engineering Clean-Black Utilities

General:

The Engineering Department at Prothya Biosolutions has about 40 engineers. Engineering is responsible for executing all investment projects in accordance with planning and within budget. The department guarantees robust installations suitable for producing high quality pharmaceutical products. We use qualification & validation tests and the necessary documentation to prove the suitability of the installation and check that it complies with the cGMP. 

We develop projects from start to finish from project definition and scope through to and including the start-up of production. The new installations are then handed over to the production & maintenance department. In addition, we build for the future in line with the site master plan. We are also a centre of expertise in the different technologies that are used for the fractionation of blood plasma into proteins to improve patients' quality of life.

Our responsibilities include Process Equipment, the required Black & Clean Utilities, as well as the engineering disciplines Civil, Mechanical, Piping, E&I, tec. During construction and installation, we monitor the building site and guarantee the safety of all ongoing activities. We also constantly looking for opportunities to innovate!

When you are part of the Engineering team, you are pivotal within the organisation and come in contact with everyone from colleagues on the work floor to the site management team!

Working with Prothya Biosolutions means working within a dynamic environment in which a flexible mindset is the key to success. This entails additional challenges but also opportunities! As a potential candidate you must be able to adapt to this changing framework, assist in creating success for the company, and be able to transfer this to the involved parties & colleagues.

Objectives

  • As a Senior Project Engineer, you are responsible for the successful implementation of projects (Clean & Black utilities), both in the role of project engineer and project manager.

  • You will accrue the required technical knowledge and propose innovative ideas to continuously improve Clean & Black Utilities (Compressed air, Clean steam, Water for injection, City water & sanitary water, Cooled water, Hot water, Glycol, Industrial steam, Ethanol, HCl, NaOH, CH3COOH, and Filter aid).

  • You are responsible for a selected number of clean/black utilities as the System Owner for which you will act as a single point of contact and SME within the company. This means defining continuous improvement for these systems and providing operational support in the event of exceptional breakdowns.

    You ensure the communication with all internal stakeholders and all external partners (suppliers, contractors, engineering firms, etc.) is transparent, smooth, and effective.

  • You prepare business cases to justify new projects
  • You perform capacity and engineering calculations.
  • Principle tasks and responsibilities:

    As Senior Project Engineer Clean & Black Utilities you are able to lead projects yourself and a (multidisciplinary) cross-departmental project team. To this end, you ensure a clear division of tasks within the project team while following the PIBe project management system.

  • From the start of the project, in consultation with internal customers, you provide a clear description of the project scope (production, maintenance, QA, EHS, etc.). You translate these customer expectations into specifications for further project development.

  • In terms of Project Engineering, you are responsible for basic and detailed design in line with project objectives and site specifications and requirements.

  • You are able to draw up a detailed schedule in line with the general project planning and ensure timely delivery of the projects within budget. You also report any deviations to the management team in a timely manner.

  • You coordinate the procurement activities (equipment & services) by writing invitations to tender and tender dossiers (contractor management).

  • You carry out the necessary risk analyses (HAZOP, FMEA) and ensure there is proper documentation.

  • You coordinate and supervise the installation of the equipment and carry out the verification/qualification/validation tests. 

  • Thereafter, you draw up a complete as-built file and complete the handover of the project to production and maintenance.

  • You manage projects with a budget between €100 and €500K.

    The projects are varied, ranging from process/productivity improvement to quality or safety improvement, modification of existing production lines, etc.

    Your profile:

  • Engineering master's degree, preferably Electromechanics (Ing./Ir.)

  • Knowledge of project management systems and tools (e.g. MS Office, MS Project) 

  • A minimum of 10 years' experience in Clean and Black Utilities of which a minimum of 5 years in a Pharmaceutical company with a production environment. 

  • Knowledge of cGMP procedures and EMA/FDA requirements 

  • Experience in Pharmaceutical production, process validation, and equipment validation (more than 5 years).

  • Strong planning skills 

  • Strong communication skills 

  • Strong organisational skills 

  • Team player and team coach versed in different disciplines 

  • Analytical and structural attitude 

  • Meticulous

  • Self-reliant and flexible

  • Proactive and problem-solving skills with a wide interest 

  • You speak and write fluent English, Dutch and/or French

    Our Company 

    Prothya Biosolutions produces plasma preparations (including known products such as Cofact, Nanogam and Albuman). In addition, Prothya collects, tests and supplies blood plasma to purification and production sites worldwide. Prothya Biosolutions' mission is to provide healthcare organizations worldwide with high-quality plasma products. The company does this by creating value for partners and contributing to the health of people who depend on essential plasma proteins. Hence, Prothya's slogan: Creating Value, Sustaining Life. The company has various office and production locations in the Netherlands and Belgium and employs around 1,000 people.

    Daarboven, hechten wij veel belang aan wederzijds respect en diversiteit is onze kracht. Voor iedereen bij Plasma Industries, van Operator tot Laborant, van Supervisor tot Manager, betekent engagement: zelf het initiatief nemen. We verwachten van elke medewerker dat hij/zij betrokken is bij de gemeenschappelijke doelstellingen die onze organisatie naar een volgende uitdaging en succes leiden. We offer

    Prothya Biosolutions BE is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.

    In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions BE offers once a year.

    We also offer an attractive holiday system exceeding the legal holidays.

    Furthermore, we value mutual respect and diversity is our strength.

    For each Prothya Biosolutions BE employee, from operators to the CEO, engagement means showing initiative. We expect all colleagues to contribute to achieving our annual objectives in order to take the organization towards it future challenges and successes.

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    Sr Engineer - Engineering

    Company:
    Plasma Industries
    City:
    Brussels
    Contract type: 
    Freelance, Full-time
    Degree level: 
    Master
    Published:
    06.01.2022
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