GMP Manufacturing Engineer (NL/EN)

To support the development and continuous improvement of a large-scale biopharmaceutical manufacturing facility, we are looking for a Manufacturing Engineer to join production support activities within a highly regulated GMP environment.

You will act as a key link between Manufacturing, Process Engineering, Quality, MSAT, and operational teams, ensuring the reliable execution of production activities while supporting process robustness, compliance, and continuous improvement initiatives.

The role combines day-to-day production support with engineering and process-related activities, offering exposure to complex biopharmaceutical manufacturing operations and ongoing optimization projects.

ABOUT THE POSITION:

As a Manufacturing Engineer, you will provide technical support to manufacturing operations and contribute to process performance, compliance, and operational excellence.

Manufacturing Support

• Provide day-to-day support to production teams during manufacturing operations.
• Act as the first technical point of contact for process-related issues and deviations.
• Support troubleshooting activities and coordinate investigations to identify root causes.
• Ensure manufacturing activities are executed in accordance with GMP requirements and internal procedures.

Batch Record Management

• Review, update, and optimize Batch Records to ensure accuracy, compliance, and operational efficiency.
• Support the implementation of process changes through the appropriate change control processes.
• Investigate manufacturing events and ensure appropriate documentation is completed.
• Contribute to deviation management and CAPA implementation.

CAPA & Continuous Improvement

• Lead or support CAPA investigations resulting from deviations, audits, and manufacturing events.
• Perform root cause analyses and define effective corrective and preventive actions.
• Monitor CAPA effectiveness and ensure timely closure.
• Identify opportunities to improve process reliability, compliance, and manufacturing performance.

Process & Project Support

• Support process validation, qualification, and continuous process verification activities.
• Participate in technology transfers, process optimization projects, and manufacturing improvements.
• Collaborate with Engineering, Quality, Validation, and Supply Chain teams to support operational readiness.
• Contribute to productivity, digitalization, and operational excellence initiatives.

ABOUT YOU:

• Bachelor's or Master's degree in Biotechnology, Bioengineering, Chemical Engineering, Pharmaceutical Sciences, Industrial Engineering, or a related field.
• 2+ years of experience within a pharmaceutical, biopharmaceutical, or highly regulated GMP environment.
• Experience supporting manufacturing operations, batch record management, deviations, and CAPA processes.
• Good understanding of GMP requirements and pharmaceutical production processes.
• Professional proficiency in Dutch and English.
• ABOUT US:

Vulcain Engineering is a group specialized in the energy sector that supports companies active in Renewable & Nuclear Energy, Gas & Infrastructure through our Study Offices and Consultancy services. Vulcain Engineering Group is positioned as a transformation partner thanks to its ultra-specialization in strategic sectors which positively impact the transformation of our society and supports its clients in their transformation towards more sustainable and responsible models. Vulcain supports its clients throughout the entire life cycle of their projects, from design to commissioning, by integrating constructability and safety requirements right from the design phase.

In Belgium, our activities focus on consultancy services, delivering expertise in three main areas:

• Energy/Infrastructure
• Gas Renewables & Processes
• Life Sciences

With headquarters based in Brussels, and clients spread all over the country, we address key projects in the Belgian industry, offering our consultants the opportunity to work on challenging topics and discover different areas during their time at Vulcain.

Why would you apply?

• An annual gross salary ranging from 45 000€ to 52 000€ paid over 13,92 months and advantages such as a company car (and fuel card), representation fees, insurances, meal vouchers, eco cheques, a sectorial bonus (the salary indicated corresponds to the level of experience mentioned in the job description. For any other level of experience, the annual salary may vary accordingly)
• A tailored career path within the company : opportunities to discover different business units, training, follow-up from your business manager, and a development evaluation every year
• A human-based company with slightly more than 120 consultants and synergies between the different business units