Project Engineer
€4,700 - €6,760 per year
Key Skills
Job Description
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.
Core Responsibilities
Deliver engineering projects and technical solutions for production processes, equipment, and facility systems, from concept and design through implementation, commissioning, and handover. Coordinate with operations, quality, validation, maintenance, suppliers, and contractors to ensure solutions meet GMP, safety, operational, and business requirements.
Requirements
Requires a bachelor’s degree in a relevant engineering discipline and several years of engineering experience in pharmaceutical, biotechnology, chemical, or another regulated production environment. Candidates should have experience with production equipment, project execution, GMP, commissioning, qualification and validation, technical specifications, design reviews, supplier coordination, and FAT activities.
Benefits
- Professional Development Opportunities
- Career Growth Opportunities
- Competitive Salary
- Attractive Employment Conditions
About Prothya Biosolutions
Industry: Pharmaceutical Manufacturing
Company size: 1,001-5,000 employees
Prothya Biosolutions was formed in 2021, when Plasma Industries Belgium (PIBe), with roots in the Belgian Red Cross, integrated with Sanquin Plasma Products (SPP), a former subsidiary of the Sanquin Blood Supply Foundation (Stichting Sanquin Bloedvoorziening). Prothya Biosolutions offers over 60 years of experience in the collection of blood plasma and production of plasma-derived medicinal products, and a long legacy of collaboration, innovation, and delivery of science-based solutions. Thanks to our diverse background, we recognize the unique value of plasma-derived medicinal products for people and society, and reflect this in our ongoing transformation into a results-driven and global organization. Stable plasma derivatives such as clotting factors, immunoglobulins and albumin solutions are produced with the fractions isolated by Plasma Industries. At Prothya, we believe the best medicines are already in your body. The human plasma proteome holds the promise of a revolution in disease diagnosis and therapeutic treatment. We will continue to play a leading role in discovering how the abundance and structure of proteins can change the way we treat human diseases. Prothya Biosolutions processes around 3 million liters of plasma each year for several international partners. This change in focus entailed a change in corporate culture. Prothya has a clear vision we call DRIVE, embodying the core values on which our organization is founded. Do you want to play an active role in improving the health of millions of patients? Would you like to be our partner or future colleague at the forefront of new developments in the Protein Therapy Development, Processing and Manufacturing? Then you are welcome at Prothya Biosolutions!