Randstad InHouse Services, specialty Pharma, is looking for a Product and Process Engineer. As a Product and Process Engineer, you will coordinate, plan, and execute technical aspects of development, validation, and transfer of manufacturing and packaging processes and equipment cleaning procedures. You will also contribute to identifying process and productivity improvement solutions. Responsibilities This role offers the opportunity to lead key activities to advance your career. Responsibilities include: Technical coordination, planning, and execution of development and validation activities for manufacturing and packaging processes, including the transfer of new products, improvement and maintenance of current processes, and qualification of new raw materials (active ingredients/excipients) and packaging components. Preparation and review of documentation required for development and validation trials, such as protocols, reports, operative instructions, sampling plans, control charts, Master Formulas, and production orders. Coordination, planning, and execution of development and validation activities for equipment cleaning procedures. Updating SOPs to regulate department activities in line with company guidelines and regulations. Providing technical support to other plant functions (QA, QC, Regulatory, Procurement, Engineering) for the evaluation and preparation of documents such as Change Controls, Master Formulas, deviations, investigations, Risk Assessments, Technical Assessments, Periodic Product Reviews (PPRs), User Requirement Functional Specifications (URFS), and HACCP manuals. Collecting and evaluating process data (in-process control) and QC analytical data for report preparation. Supporting Production with technological issues during commercial production. Offering technical support to Operations and Opex for continuous improvement initiatives aimed at enhancing performance, productivity, and reducing losses. This position is based in Aprilia (Lt), Italy. J-18808-Ljbffr