We are currently recruiting a Project Engineer with (technical) expertise of cleaning systems (CIP, parts washers), SIP or autoclaves, dry heat, VHP or isolator technology or other process technologies (e.g. filling) related to pharmaceutical processes. With experience of design, installation, testing, verification and validation of equipment. The successful candidate should be up and running fast in multiple projects so pharma experience preferred. Able to work on multiple qualification projects.
The tasks for the Project Engineer:
- Responsible for project engineering activities related to specific technology, equipment or process installation.
- 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 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).
- Strict adherence to safe working practices as set out in the safety statement and other company safety rules
- Control and monitor the safe working practices of contractors while on site
- Understanding of Environmental Health & Safety Requirements on a Pharmaceutical Plant
- Experience in executing Engineering (Capex) projects, Experienced in planning and project coordination (MS Project is a plus)
- Good communication skills
- Pragmatic, pro-active, can take the lead
- Able to motivate
- Results focused
- Able to work independently but is also a team player
- Quality minded – experience in pharma (GMP, risk assessments, verification & validation)
- Hands-on and good problem solving skills
- Shows ownership
- Good documentation skills, able to deliver clear and complete documents
- Good knowledge of Dutch and English
All applications are treated in strictest confidence
RECRUITMENTS AGENCIES NOT REQUIRED