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 plusExperience in validation is a big plusAffinity with the pharma sector is a mustProject coordination / contractor management is a plusTechnical / scientific Master is a must : industrial, civil or bio engineer is a mustStrong communication skillsStrong organizational skillsTeam playerAnalyticalPunctual, pro-activeCan work independentlyAssertiveHigh interest in technical / technological and process related aspectsCan handle frequent changes in project / environment