Process & system Engineer

MediWound is seeking an experienced and highly motivated Process and System Engineer to join our MS&T team.

This role is responsible for supporting, improving, and scaling biopharmaceutical manufacturing processes, with a strong focus on technology transfer, process scale-up, engineering support, validation activities, and continuous process improvement. The position requires a hands-on engineering approach, a strong understanding of GMP production environments, and the ability to work cross-functionally with Engineering, Validation, Quality, Manufacturing, and external subcontractors.

The ideal candidate will bring significant experience in pharmaceutical or biopharmaceutical manufacturing, process engineering, and regulated environments, and will play a key role in ensuring robust, scalable, compliant, and continuously improving manufacturing processes.

What will you do?

Process support

• Responsible for Tech Transfer and scale-up of the production process, including exploring new technologies to enable efficient and robust scale-up, data preservation, protocol writing and process improvements

• Writing all tech transfer documentation, protocols, reports, gap analysis according to relevant guidelines

• Responsible for supporting and setting the policy and actual implementation of all processes and engineering aspects including constant improvement of existing and new processes.

• Develop robust process control strategies, including automation and advanced analytics, to enhance manufacturing consistency and scalability.

• Accompanying and supporting the planning and execution of validation for processes and equipment under the department's responsibility.

• Responsible for the initiation and execution of change requests, deviations, and corrective actions in accordance with the procedures and quality systems of the company.

• Work closely with the engineering & validation department, also engineering subcontractor company to ensure that engineering projects are completed on time and within allocated resources.

• Lead and apply advanced engineering principles to optimize biopharmaceutical manufacturing processes, including UF process, lyophilization procedures and fill-finish operations.

• Utilize engineering methodologies (e.g., process modeling, data analysis, control systems design) to ensure scalable, efficient, and cost-effective production.

• Ensure that all engineering and process design work complies with relevant regulatory standards (FDA, EMA, ICH) and cGMP guidelines, maintaining a state of readiness for audits and inspections.

What should you have? Education

• Bachelor’s, Master’s, or PhD in Chemical Engineering, Biochemical Engineering, Mechanical Engineering, or a related engineering field.

Experience

• Minimum of 7 years of experience in biopharmaceutical or pharmaceutical manufacturing, focusing on process engineering with hands on familiarity with cleanrooms and GMP production areas.

• Significant experience in managing complex engineering projects within regulated environments (FDA, EMA).

• Advantage to experience with aseptic processing, powder handling, and isolator technology.

Skills

• Expertise in engineering aspects of biopharmaceutical manufacturing, including scaled down and fill &finish process and equipment, such as lyophilizer, UF and isolator.

• Proficiency in process development, scale-up, optimization, and validation for commercial products.

• Deep knowledge of regulatory requirements (FDA, EMA) and cGMP standards as applied to engineering design and process operations.

• Previous experience in leading tech transfer of production process in the pharma industry or equivalent.

• Strong communication skills, with the ability to collaborate across functions and present complex engineering concepts to non-technical stakeholders.

• Strategic and analytical thinker with strong problem-solving skills and a hands on practice approach.