Project Engineer

At Prothya BioSolutions, we develop and manufacture life-saving plasma-derived medicines that improve the lives of millions of patients around the world. Every day, our colleagues are driven by a shared purpose: delivering high-quality therapies while continuously improving our processes, technologies, and ways of working. Joining Prothya means becoming part of an innovative and dynamic environment where collaboration, flexibility, and a commitment to excellence are essential to success.

We are looking for an experienced Project Engineer to join our engineering team within a regulated production environment. In this role, you will be responsible for delivering technical projects and engineering solutions related to production processes, equipment and facility systems. You will manage engineering activities from initial concept development through design, implementation, commissioning and handover. By working closely with Operations, Quality, Validation, Maintenance, suppliers and contractors, you will ensure that technical solutions meet operational needs, GMP requirements, safety standards and business objectives.

Your responsibilities

Engineering & Technical Solutions

• Investigate production processes and equipment to identify improvement opportunities.
• Translate operational, technical, quality and regulatory requirements into effective engineering solutions.
• Develop technical concepts and evaluate alternative solutions.
• Perform engineering studies, analyses, trials and technical assessments.
• Evaluate technical feasibility, safety, GMP compliance, costs and operational impact.

Technical Design & Supplier Coordination

• Prepare user requirements, technical specifications and engineering documentation.
• Ensure process, equipment, automation, facility, safety and validation requirements are incorporated into designs.
• Participate in design reviews and identify technical gaps, risks and interfaces.
• Review supplier quotations, technical proposals and documentation.
• Support Factory Acceptance Tests (FATs) and supplier evaluations.
• Coordinate technical activities with suppliers and contractors.

Project Engineering & Execution

• Deliver engineering work packages within multidisciplinary projects.
• Lead smaller engineering projects from scope definition through implementation.
• Define project activities, deliverables, planning, resources and costs.
• Coordinate design, installation, commissioning and technical testing activities.
• Monitor progress, quality, risks and budget within the assigned scope.
• Report project status and escalate issues impacting scope, planning, cost or operations.

Commissioning, Qualification & GMP Compliance

• Ensure equipment and systems comply with approved requirements, GMP standards and safety regulations.
• Provide engineering support during commissioning, qualification and validation activities.
• Prepare and execute technical tests together with Quality, Validation and Operations.
• Review technical documentation and ensure accuracy and completeness.
• Resolve technical deficiencies and support successful operational handover.
• Provide technical input during audits and inspections.

Problem Solving & Continuous Improvement

• Investigate technical issues and equipment failures.
• Perform root cause analyses and assess risks related to quality, safety, cost and production continuity.
• Develop and implement corrective and preventive measures.
• Support deviations, CAPAs and change control processes.
• Identify opportunities to improve engineering standards, processes and working methods.

Technical Coordination & Knowledge Transfer

• Coordinate technical activities with engineers, specialists, users, suppliers and contractors.
• Organise technical reviews and follow up on agreed actions.
• Prepare technical procedures, work instructions and maintenance documentation.
• Transfer equipment knowledge and documentation to operational teams.
• Provide technical support during start-up and initial production.

Safety & Compliance

• Follow all applicable EHS procedures and company safety requirements.
• Use personal protective equipment correctly.
• Proactively identify and report unsafe conditions and environmental incidents.

What you bring

• Bachelor’s degree in Process Engineering, Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering or a related technical discipline.
• Several years of engineering experience within a pharmaceutical, biotechnology, chemical or other regulated production environment.
• Experience with production equipment, process improvements and engineering project execution.
• Knowledge of GMP requirements, commissioning, qualification and validation processes.
• Experience with technical specifications, design reviews, supplier coordination and FAT activities.
• Strong analytical and problem-solving skills.
• Ability to coordinate multidisciplinary teams and manage technical interfaces.
• Structured, accurate and quality-focused working approach.
• Good communication skills in English.

What we offer

• A challenging engineering position within a highly regulated and innovative environment.
• Salary range € 4.702,26 € 6.759,41
• The opportunity to work on impactful technical projects and process improvements.
• Collaboration with multidisciplinary teams and technical experts.
• Opportunities for professional development and growth.
• A competitive salary and attractive employment conditions.