Overview To support an important project for a client in the pharmaceutical sector in the region of Brussels, we are urgently searching for an experienced PROCESS PROJECT ENGINEER.
PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.
Our Vision is to be a highly valued and creative delivery partner, building a more sustainable world with our clients.
Our OTS (Outsourced Technical Services) department supports projects in different sectors on basis of project staffing with consultants working at the client’s site.
Responsibilities Technical Coordination
- Planning of all the technical activities
- Technical troubleshooting (definition of: issue, root cause, corrective action) together with
engineering contractors. - Follow-up of the implementation of the corrective actions. + re-test when needed.
- Ensure that the systems are technically ready for the execution of the water runs and for the hand over.
- Responsible of the hand over to maintenance and user.
Documentation
- Support SAT activities in its area of expertise
- Review and approve the updated technical documentation
- Organize the training of the final user in its area of expertise & provide technical documentation in
to finalize the Hand-over - Create and manage Technical changes when needed to ensure that the systems are fully compliant
with URS. - Actively perform the tasks to an efficient Hand-over in its area of expertise, with the follow-up of
the associated punchlist - Respect documentation strategy
HSE
- Ensure compliance to HSE requirements and rules
Qualifications Requirements:
- Minimum 5 years of experience within pharmaceutical companies and working with Engineering offices
- Experience during Handover Phase of a project (any project).
- In-depth technical experience in a regulated environment, biologicals, pharmaceutical and engineering operations
- Experience in single use systems within the pharmaceutical industry
- Large experience in equipment installation and commissioning
- Good understanding of EHS (Environment, Health and Safety) and Quality aspects (GMPs)
- Experience of engineering of process equipment and interaction with Engineering contractors.
- Background within manufacturing USP (UpStream Process Equipment – bioreactors, UF Filtration skid) & DSP (DownStream Process equipment - Single use Chromatography skids, Single use TTF & VRF skids, Single use mixers)
- Good knowledge of Media buffer production equipment (single use mixer, single use tote, single use aseptic connections, single use bags)
- Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required.
- Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
- Knowledge in qualification & validation approaches (especially ASTM E2500) is highly relevant
- Good knowledge of cGMPs
- Experience in large and complex projects as well as both formal and informal leadership /coordination
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click HERE to read more in our ‘Corporate Responsibility and Health, Safety and Wellbeing Report’.
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