Process engineer (pharma) - 106643
We're hiring a Medior Process Engineer to join our dynamic team in the pharmaceutical sector! If you're passionate about optimizing manufacturing processes and ensuring top-quality production standards, we want to hear from you.
Our client is a global vaccine research, development and production company, that employs over 90,000 people worldwide, of which 9,000 in its three Belgian sites: Rixensart, Wavre and Gembloux.- key responsibilities
Mission description:
In coordination with Engineering Office and Project Management, ensure correct design, construction, commissioning and qualification in full compliance with internal requirements and authorities' requirement of Secondary equipments and Aseptic technologies package.
Related to these packages, it includes :
-Being client's representative for all Secondary equipments-related activities and installations- Supporting the E.O in management of activities related to this package
- Ensure regular technical contact with MPU representative (User, QA, Validation, Maintenance,…)
- Ensuring alignment between E.O and client's Specification and Guidance
- Reviewing design and technical documentation
-Following-up construction & all testing activities falling under the package’ scope
-Ensure systems start-up and punchlist solving- Writing and executing commissioning and qualification protocols/reports
- Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
- Facilitating handover process towards the end user
- qualifications
In the expertise domain of pharmaceuticals Secondary equipments and Aseptic technologies systems, needed capabilities embrace:
Hard Skills
Demonstrates deep knowledge and expertise in design, implementation and qualification of engineering projects.
Key capabilities include:
- Definition of functional, technical and quality requirements.
- Realisation of reviews of process studies, P&ID’s and layouts
- Oversight contractor's performance.
- Integration of operability and EHS requirements at all design steps.
- Preparation of the project testing, commisioning and inspection requirements
- Organize legal conformity visits
- On-site verification of execution according to good practices
- Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…),..
- Team working & Communication / Autonomy / Contractors' management.
- Good project integration experience: organisation, schedule, qualification, validation, technologies.
- Experience in the Pharmaceutical industry
- Perform his/her work in an EHS and cGMP high-demanding environnement.
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