Operations — Engineering/production
Minimum level of experience required
All levels of experience
Antwerp, Flanders, Belgium
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AKKA is an international engineering consulting and R&D services company. As an innovation accelerator for its clients, AKKA supports leading industry players in the automotive, aerospace, rail, space, defense, energy and life sciences sectors throughout the life cycle of their products with cutting edge digital technologies
With more than 22.000 experts in over 25 countries, AKKA is one of the leaders in its field. In Belgium, we have close to 1000 experts active in different technical fields.
- You will be responsible for project engineering activities related to filling equipment and/or for process technologies related to pharmaceutical filling processes.
- You provide technical input in the project team for own discipline.
- You define and document the technical specs (Engineering Design
- Specification or technical spec, P&ID’s, electrical diagrams) and reviews with the relevant SME.
- You follow the engineering standards and align with the lead engineer during design, construction and implementation.
- You follow up the construction, implementation and functioning of the equipment to guarantee the installation is according to spec.
- You guarantee good project management practices and tools (schedule, budget control, issues, decisions, reporting, stakeholder management, …) for own equipment/installation/scope.
- You keep oversight of the contractor company that will build, install or test the equipment.
- You are responsible for transfer to operations of own equipment, delivering all project documentation and close out of the project. Follow start up results to guarantee that the project deliverables were achieved.
- Assure correct documentation of construction and verification/validation on the engineering project folder.
- Responsible for defining and executing the engineering tests, verification and validation of own equipment. You define the validation approach, create test protocols for engineering tests, create verification and validation documents, execute tests, coordinate SME and system owner approvals. You are responsible to solve and document deviations and actions (CAPA’s, risk assessments, CGMP review, new document versions).
- You have technical and operational knowledge and expertise. Know how a filling installation or system functions and know the requirements (operational/technical/compliance).
- Experience in executing Engineering (Capex) projects and experienced in planning and project coordination (MS Project is a plus)
- Quality minded – experience in pharma (GMP, risk assessments, verification & validation)
- Experience with testing, verification and validation of filling equipment within sterile environment.
- Soft skills: Good communication skillsn pragmatic, pro-active, can take the lead, able to motivaten, results focused, able to work independently but is also a team player, hands-on and good problem solving skills, shows ownership, good documentation skills, able to deliver clear and complete documents
- You speak a good level of English
As an AKKA consultant, you will be:
- In charge of diverse transversal and empowering projects
- Supported in your career by your AKKA Manager
- Actor of your training plan and your personal and professional development
- Member of a dynamic and collaborative community of engineers
- Benefiting from a permanent contract
- Benefiting from a competitive salary packages including several extra-legal benefits.
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