STAR is looking for a Project Engineer with technical expertise of aseptic formulation processes and equipment (utility panels, mixers, cooling of tanks, .
Focus on manufacturing processes, not on (chemical) drug substance. General Tasks : Responsible for project engineering activities related to specific technology, equipment or process installationProvides 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 PM 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).
Profile : Experience in executing Engineering (Capex) projects, Experienced in planning and project coordination (MS Project is a plus)Good communication skillsPragmatic, pro-active, can take the leadAble to motivateResults focusedAble to work independently but is also a team playerQuality minded experience in pharma (GMP, risk assessments, verification & validation)Hands-on and good problem solving skillsShows ownershipGood documentation skills, able to deliver clear and complete documents41905