Lead Engineer, Fill & Finish Systems — Hybrid

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

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.