Process & system Engineer
MediWound · JB-241
Normalized fields
open- Function
- digital_it
- Business unit
- Not classified
- Location
- Not provided
- Work model
- Not classified
- Seniority
- Not classified
- Clearance
- Not provided
- Employment type
- Not provided
- Compensation
- Not provided
- First seen
- 2026-09-09T06:00:37.626Z
- Last seen
- 2026-10-12T06:00:33.956Z
- Requisition
- JB-241
Latest version
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. Responsibilities: 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. Requirements: 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
Derived classifications
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