Lead Engineer | Fill & Finish Systems | Brussels

Prothya Biosolutions; Brussel Hoofdstad; Hybride; EUR 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Group insurance

Hospitalization insurance

Meal vouchers

Company Car

Flex Reward Plan

Training & development

Hybrid working

Collaborative environment

Impactful work

Résumé du poste

Prothya Biosolutions Belgium is seeking a Lead Engineer Fill & Finish Systems in Brussels to act as technical authority for critical manufacturing systems, define roadmaps and ensure lifecycle performance.

You will lead cross-functional teams, drive continuous improvement, ensure GMP compliance and partner with Operations, QA and Validation to deliver robust, future-proof solutions in a dynamic biopharmaceutical environment.

Qualifications

• Minimum 8 years of professional engineering experience.
• At least 3 years in a senior or lead engineering role within a GMP-regulated pharmaceutical, biotech or life sciences environment.
• Experience with Fill & Finish, aseptic processing or sterile manufacturing is a strong asset.
• Strong knowledge of GMP, GEP and pharmaceutical engineering standards.
• Experience with project management methodologies.
• Familiarity with lifecycle management, qualification and validation activities.

Responsabilités

• System Architect: Define and maintain a future-oriented roadmap for one or more technical domains, including equipment, utilities, automation and OT systems.
• System Architect: Monitor industry developments, GMP requirements and emerging technologies to continuously improve engineering standards.
• System Architect: Conduct feasibility studies, capacity analyses and technical assessments to support strategic business decisions and investment projects.
• Technical System Owner: Act as the technical owner of critical manufacturing systems throughout their lifecycle.
• Technical System Owner: Maintain deep technical expertise and ownership of system design, performance and compliance.
• Technical System Owner: Perform design reviews and ensure engineering documentation remains accurate and up to date.
• Subject Matter Expert (SME): Provide expert technical guidance and coaching to engineers and project teams.
• Projects & Continuous Improvement: Develop business cases for system improvements and investments.
• Projects & Continuous Improvement: Lead and support multidisciplinary engineering projects.
• Projects & Continuous Improvement: Apply project management and lifecycle management principles to ensure successful project delivery.
• Projects & Continuous Improvement: Contribute to the development of robust, compliant and future-proof manufacturing systems.
• Leadership: Lead cross-functional project teams and technical workstreams.
• Leadership: Foster collaboration across departments and stakeholders.
• Leadership: Promote a culture of safety, quality and continuous improvement.
• Leadership: Mentor and support engineers within your area of expertise.
• Stakeholder Management: Collaborate effectively with Operations, QA, Validation, Maintenance, Automation and other internal departments.
• Stakeholder Management: Build strong relationships with external partners, suppliers and contractors.
• Stakeholder Management: Align technical solutions with business objectives and operational needs.

Connaissances

Technical leadership

GMP knowledge

Project management

Lifecycle management

Stakeholder management

Formation

Master of Engineering Technology (Industrial Engineer)

Master of Engineering Science (Civil Engineer)

Description du poste

Lead Engineer | Fill & Finish Systems | Brussels

Join Prothya Biosolutions and help shape the future of life-saving plasma medicines

At Prothya Biosolutions, we develop and manufacture life-saving plasma-derived medicines that improve the lives of millions of patients worldwide. As a growing international biopharmaceutical company, we offer a dynamic environment where innovation, expertise and collaboration drive everything we do.

To strengthen our Engineering team in Brussels, we are looking for a Lead Engineer Fill & Finish Systems.

Your Role

As a Lead Engineer, you act as the technical authority and system architect for critical Fill & Finish manufacturing systems. You define long-term engineering roadmaps, provide technical leadership, and ensure the reliability, compliance and performance of systems throughout their lifecycle.

You are a subject matter expert within your domain and play a key role in supporting strategic investments, technical improvements and operational excellence initiatives.

Key Responsibilities

System Architect

• Define and maintain a future-oriented roadmap for one or more technical domains, including equipment, utilities, automation and OT systems.
• Monitor industry developments, GMP requirements and emerging technologies to continuously improve engineering standards.
• Conduct feasibility studies, capacity analyses and technical assessments to support strategic business decisions and investment projects.

Technical System Owner

• Act as the technical owner of critical manufacturing systems throughout their lifecycle.
• Maintain deep technical expertise and ownership of system design, performance and compliance.
• Perform design reviews and ensure engineering documentation remains accurate and up to date.
• Support manufacturing operations in troubleshooting activities, root cause investigations and implementation of sustainable solutions.

Subject Matter Expert (SME)

• Provide expert technical guidance and coaching to engineers and project teams.
• Promote best engineering practices and contribute to continuous improvement initiatives.
• Serve as the go-to expert within your area of specialization.

Projects & Continuous Improvement

• Develop business cases for system improvements and investments.
• Lead and support multidisciplinary engineering projects.
• Apply project management and lifecycle management principles to ensure successful project delivery.
• Contribute to the development of robust, compliant and future-proof manufacturing systems.

Leadership

• Lead cross-functional project teams and technical workstreams.
• Foster collaboration across departments and stakeholders.
• Promote a culture of safety, quality and continuous improvement.
• Mentor and support engineers within your area of expertise.

Stakeholder Management

• Collaborate effectively with Operations, QA, Validation, Maintenance, Automation and other internal departments.
• Build strong relationships with external partners, suppliers and contractors.
• Align technical solutions with business objectives and operational needs.

Who Are You?

Education

• Master of Engineering Technology (Industrial Engineer) or Master of Engineering Science (Civil Engineer), or equivalent through experience.

Experience

• Minimum 8 years of professional engineering experience.
• At least 3 years in a senior or lead engineering role within a GMP-regulated pharmaceutical, biotech or life sciences environment.
• Experience with Fill & Finish, aseptic processing or sterile manufacturing is a strong asset.

Technical Skills

• Strong expertise in one or more technical domains such as process equipment, utilities, automation, OT or electrical systems.
• Sound knowledge of GMP, GEP and pharmaceutical engineering standards.
• Experience with project management methodologies and related tools.
• Familiarity with lifecycle management, qualification and validation activities.

Personal Competencies

• Strong analytical and problem-solving skills.
• Proactive and results-driven mindset.
• Excellent communication and stakeholder management skills.
• Capable of influencing and leading without formal authority.
• Innovative, customer-focused and continuous improvement oriented.
• Team player who can also work independently.

Languages

• Fluent in English, combined with Dutch and/or French.

What We Offer

Prothya Biosolutions Belgium is part of an international biopharmaceutical group that offers long-term career opportunities and invests strongly in employee development.

In addition to a competitive salary package, we offer:

• Group and hospitalization insurance
• Meal vouchers and eco vouchers
• Company Car
• Flex Reward Plan
• Extensive training and development opportunities
• Attractive holiday scheme above statutory requirements
• Hybrid working opportunities after successful onboarding
• A collaborative and innovative working environment
• The opportunity to contribute directly to life-saving therapies

At Prothya, diversity is our strength and mutual respect is at the heart of everything we do.

Ready to make an impact?

Join us and help build the future of life-saving plasma medicines.