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Senior Project Engineer
Prothya Biosolutions Netherlands B.V.
About the role
We are looking for an experienced and driven Senior Project Engineer to lead complex engineering projects within a highly regulated production environment. In this role, you will be responsible for translating operational, technical, quality, regulatory, and business requirements into robust engineering solutions while ensuring compliance, efficiency, safety, and long-term reliability.
You will work closely with multidisciplinary teams, including Operations, Validation, Quality, Maintenance, and external suppliers, to deliver engineering projects from concept development through commissioning and operational handover.
What you'll do
Process and equipment engineering
Develop concepts for processes, equipment, and production lines.
Translate technical, operational, quality, and regulatory requirements into practical engineering solutions.
Evaluate design principles and technical alternatives.
Lead engineering studies, trials, and test activities.
Provide expert advice regarding technical feasibility, safety, GMP compliance, lifecycle costs, and operational impact.
Technical design and supplier management
Define and approve user requirements, specifications, and design criteria.
Integrate process, mechanical, electrical, automation, facility, safety, and validation requirements.
Lead design reviews and identify technical gaps, interfaces, and risks.
Evaluate supplier proposals and support supplier selection processes.
Coordinate supplier assessments and Factory Acceptance Tests (FATs).
Manage suppliers and contractors throughout the project lifecycle.
Technical project leadership
Lead engineering activities across multiple work streams and project phases.
Define project scope, technical deliverables, resource requirements, and timelines.
Coordinate multidisciplinary engineering teams.
Monitor progress, quality, risks, budgets, and technical performance.
Prepare recommendations and technical proposals for project stakeholders.
Compliance, commissioning, and validation
Ensure that all systems, equipment, and designs comply with applicable GMP, quality, and safety standards.
Coordinate engineering activities related to commissioning, qualification, and validation.
Review technical documentation for completeness and accuracy.
Evaluate test results and ensure the implementation of corrective actions.
Support audits, inspections, and operational handover activities.
Problem-solving and continuous improvement
Lead investigations into complex technical issues and deviations.
Perform root-cause analyses and implement sustainable solutions.
Support change control processes and CAPA implementation.
Contribute to the development and improvement of engineering standards, procedures, and best practices.
Leadership and coaching
Coordinate and guide engineers, specialists, contractors, and suppliers.
Facilitate technical decision-making across disciplines.
Provide coaching and technical support to team members.
Promote knowledge sharing and continuous improvement.
Environment, health, and safety
Ensure compliance with all applicable environmental, health, and safety regulations.
Promote a strong safety culture and proactively identify and mitigate risks.
What you'll bring
Bachelor's or master's degree in Chemical Engineering, Mechanical Engineering, Process Engineering, Pharmaceutical Engineering, or a related discipline.
Extensive experience managing multidisciplinary engineering projects.
Experience working within a GMP-regulated environment, preferably in the pharmaceutical, biotechnology, food, or chemical industry.
Knowledge of commissioning, qualification, and validation processes.
Experience managing suppliers, contractors, and external stakeholders.
Strong analytical, communication, and leadership skills.
Excellent command of the English language.
What's on offer
An opportunity to contribute directly to the production of life-saving medicines.
Salary range € 5.290,02 € 7.604,37
A challenging and technically diverse role within a highly regulated environment.
Exposure to cross-functional teams and senior leadership.
Opportunities for professional growth and development.
A collaborative workplace culture focused on innovation, quality, and continuous improvement.
If you are passionate about engineering excellence and would like to contribute to meaningful projects that improve patients' lives, we would love to hear from you.