Senior Process Engineer

To support sevral interesting and lonterm projects for a client in the pharmaceutical sector in the region of Brussels, we are searching for an experienced PROCESS 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:

BASIC & DETAILED DESIGN

• Provide Engineering offices with the applicable standards
• Challenge technical solutions coming from Engineering office
• Integrate safety, sustainability and green assessment in the design
• Define List of Delivrables for his discipline
• Provide project delivrables of his discipline to Engineering Leader

CONSTRUCTION

• Based on progress report of the construction manager, perform on a regular basis field spot check follow-up
• Organize quality checks on field before each technical milestone activiy.
• Communicate the day to day schedule (planning level 4) to the Engineering Leader
• Ensure a good communication with other Specialists linked to its activity (Battery limits)

Documentation

• Define battery limit and RACI matrix with Engineering Leader
• Update drawings in its area of expertise
• Write commissioning documentation and ensure that the supplier's documentation is acceptable to perform verification (ASTM 2500)
• Perform FAT/SAT activities in its area of expertise
• Support the commissioning (V-Cycle and/or ASTM2500)
• 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

HSE

• Ensure compliance to HSE requirements and rules
• Ensure the 3 green lights are scheduled and correctly organized/done

Qualifications:

• Master degree
• 10+ years of relevant experience in large scale CAPEX Projects in the pharmaceutical industry
• In-depth technical experience in a regulated environment with knowledge of gene therapy, biologicals, pharmaceutical and engineering operations
• Good Expertise in single use systems within the pharmaceutical industry
  
• Leading the Process & Automation team of the project
  
• Large experience in basic/detailed design, equipment installation and commissioning
  
• Driving consistency within Engineering standards, norms and regulations
  
• Supporting qualification and validation activities
  
• Ensuring adherence to EHS regulation and Green good practices
• Very good knowledge of English; knowledge of French is also preferable

Technical skills:

• Lead the engineering process area and act as the spoc for all process equipment from design until the handover after verification.
• Organize his/her team to address to address the best engineering good practice and collaborate with key users.
  
• He/She is in the driver seat, with a full management of supplier, User, QA, EHS, C&V team and will be measure with the success of process equipment implementation.
  
• Strong background within manufacturing USP & DSP (upstream & downstream) bioprocess equipment (Single use systems: bioreactors, UF/DF filtration skids, Chromatography skids, ATF, Mixer).
  
• Good knowledge of single use equipment
  
• Good understanding and experience in automation requirements.
  
• Strong knowledge on GEP and global engineering standards.
  
• Ability to Lead P&ID and PFD setup is required
  
• Ability to act as technical process expert during HAZOP (Hazard and Operability study) / QRA (Quality Risk Analysis) / FMEA
  
• Knowledge in verification ASTM E2500 is important
  
• Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
  
• Experience in large and complex projects as well as both formal and informal leadership / coordination
  
• Excellent communication skills in order to present frequent reports to Management.

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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