A Project Engineer with technical expertise preferably in one of the following: filling equipment for process technologies related to pharmaceutical filling processes; experience with testing, verification and validation of filling equipment within sterile environment is a plus. Responsible for project engineering activities related to specific technology, equipment or process installation (filling equipment: filling lines, isolators, e-beams, washers, tunnels and/or cappers).
* Provides technical input in the project team for own discipline. Has technical and operational knowledge and expertise
* Knows how the installation or system functions and knows the internal requirements (operational/technical/compliance)
* Defines and documents the technical specs (Engineering Design Specification or technical spec, P&ID’s, electrical diagrams) and reviews with the relevant SME
* Follows the engineering standards and aligns with the lead engineer during design, construction and implementation
* Follows up the construction, implementation and functioning of the equipment to guarantee the installation is according to spec
* Guarantees good project management practices and tools (schedule, budget control, issues, decisions, reporting, stakeholder management, ...) for own equipment/installation/scope
* Keeps oversight of the contractor company that will build, install or test the equipment
* Is responsible for transfer to operations of own equipment, delivering all project documentation and close out of the project
* Follows start up results to guarantee that the project deliverables were achieved
* Assures correct documentation of construction and verification/validation on the engineering project folder. Is responsible for defining and executing the engineering tests, verification and validation of own equipment
* Defines the validation approach, creates test protocols for engineering tests, creates verification and validation documents, executes tests, coordinates SME and system owner approvals
* PE is responsible to solve and document deviations and actions (CAPA’s, risk assessments, cGMP review, new document versions)
Experience:
* Experience in a pharmaceutical environment and/or GMP in an aseptic environment is a big plus
* Experience in validation is a big plus
* Affinity with the pharma sector is a must
* Project coordination/contractor management is a plus
* Technical/scientific Master is a must: industrial, civil or bio engineer is a must
* Strong communication skills
* Strong organizational skills
* Team player
* Analytical
* Punctual, pro-active
* Can work independently
* Assertive
* High interest in technical/technological and process related aspects
* Can handle frequent changes in project/environment