Project Engineer

Skills and Knowledge required :

• Education level: Electromechanical engineer level or equivalent level achieved and demonstrated through experience, in the pharmaceutical environment.
• Required previous experience: 4 years of experience in a similar position in the pharmaceutical environment.
• Languages: French, English. German and Dutch are an asset.
• Computer knowledge required: MS Office Suite, AutoCad.
• Regulatory knowledge: EU CGMP, 21CFR, PED directive.
• Excellent written and verbal communication skills as well as good presentation skills.
• Ability to coordinate and work within cross-functional teams.
• Must demonstrate organizational skills and be able to interact with personnel at all levels within the organization from a variety of cultural backgrounds.
• Ability to work effectively under pressure and comply with timelines.
• Must be a self-starter, able to work independently and have ability to multi-task under strict deadlines.
• Detail orientated with ability to accomplish objectives through clear thinking and strong personal organizational skills.

Requirements

Responsibilities & tasks:

Manage the study, coordination, and monitoring of projects at the level of machinery, equipment, installations, constructions, buildings, etc., in order to optimize the company's equipment and processes.

Projects can involve new installations as well as significant transformations of existing ones for optimization purposes.

The tasks include:

• Study, coordination, and monitoring of projects at the level of machinery, equipment, installations, constructions, buildings, etc., while respecting internal SOPs.
• Writing and coordinating URS (User Requirement Specifications) and CC (Change Control).
• Participation in qualification activities for installations, machinery, etc.: FAT/SAT, DQ, IQ, OQ, commissioning, and participation in PQ.
• Reviewing VPE (Validation Protocol and Report) for equipment/installations/systems.
• Construction of the Technical File.
• Management of plans related to projects.
• Participating in personnel training following the implementation of a new project.
• Regular reporting on project progress to the Engineering Manager.
• Providing the Engineering Manager with possible improvements in the operation and profitability of machinery and installations (continuous improvement).
• Providing support to the Maintenance department on installations and equipment for which they are designated as support to the equipment or installation manager.
• Supporting the writing of maintenance procedures.
• Responsible for organizing the internal and external implementation of projects under their responsibility.
• Responsible for preparing and guiding the procurement of projects for which they are responsible.