Process Automation Engineer

il y a 1 semaine

Bruxelles, Région de Bruxelles, Belgique PM Group Temps plein
Overview

PM Group is looking for a 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 of 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 the 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 in the FAT/SAT of Equipment in the scope.
  • Support the qualification phases after commissioning (ASTM2500).
  • Organize quality checks in the field before each technical milestone activity.
  • Ensure good communication with other Specialists linked to its activity (Battery limits).
  • Maintain 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 to finalize the Hand-Over.
  • Actively perform the tasks for an efficient Hand-over in its area of expertise, with the follow-up of the associated punchlist.
  • Respect documentation strategy.
  • Ensure compliance with HSE requirements and rules.
  • Ensure the 3 green lights are scheduled and correctly organized/done.
Qualifications
  • Master's degree.
  • 8+ years of relevant experience in 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 specifications to process SMEs 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 (especially 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 at 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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