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Process Automation Engineer (medior)

PM GroupBrussels, Brussels Capital, BE, Netherlands

14 dagen geleden

Functieomschrijving

Overview

PM Group is looking for Process Automation Engineer (medior level) to join our OTS department and support a project on site with a client in the pharmaceutical sector in the region ofd Brussels.

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 3,600 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

Ensure technical requirements are met within automation design provided by suppliers.
Include all technical requests in the URS for the commissioning and qualification.
Ensure for its Packages that deliverables will be provided timely and aligned with project planning with the right expected quality and according to the allocated budget.
Report the progress for its Packages.
Be accountable for its Packages and in strong collaboration with Automation Integrator company.
Align design expectations with the other project disciplines : Process, QA Q / V, Utilities, E&I, etc.
Anticipate, manage and report risks from Detail Design till validation batches.
Perform Design review and Design Verification with the Engineering office and the CQV team
Lead and Participate to the FAT / SAT of Equipment in the scope
Support the qualification phases after commissioning (ASTM2500)
Organize quality checks on field before each technical milestone activity.
Ensure a good communication with other Specialists linked to its activity (Battery limits)
Maintain his knowledge accuracy based on new technology. Keep up-to-date.
Organize the training of the final user in its area of expertise & provide technical documentation in to finalize the Hand-Over
Actively perfom the tasks to an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist
Respect documentation strategy
Ensure compliance to HSE requirements and rules
Ensure the 3 green lights are schedulled and correctly organized / done

Qualifications

Master's degree

8+ years of relevant experience in in the pharmaceutical industry projects.

Expertise in Automation for Biological processes

In-depth technical experience in a regulated environment with knowledge of biologicals, pharmaceutical and engineering operations

Expertise in DCS system and preferably PCS7 (with Batch)

Large experience in detailed design, equipment installation and commissioning

Expertise in supporting qualification and validation activities

Good understanding of EHS (Environment, Health and Safety) and Quality aspects

Understand and translate Automation functional specification to process SME to ensure requirements are fully answered.

Strong background within manufacturing M&B(Media and Buffer) or USP or DSP process equipment

Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required.

Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant

Strong knowledge of cGMP / GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is required.

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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