International pharmaceutical company with a new plant in the area of Barcelona Project with high impact in the company and visibility
A well-established and internationally expanding pharmaceutical company is setting up a manufacturing and R&D; facility in Vallès Occidental (Barcelona) - and we're looking for a Senior Process & Project Engineer to play a key role in this journey.
The new site will operate as a Contract Manufacturing Organization (CMO), specializing in aseptic filling of generic and biosimilar products. Provide technical support and expertise for aseptic filling operations, including vial and prefilled syringes filling, isolators, lyophilization, capping and packaging.
Perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues.
Prioritize and implement process change requirements based on the critical project needs.
Collaborate with cross-functional teams, including manufacturing, quality, and validation, to develop and implement process improvements, ensuring optimized and efficient manufacturing operations, as well as compliance with regulatory requirements and industry best practices.
Identify and resolve technical issues related to equipment, processes, and quality deviations.
Conduct process investigations and root cause analyses to identify and address deviations, non-conformances, and other process-related issues, implementing corrective and preventive actions as necessary.
Develop and implement process control strategies to improve product quality, yield, and efficiency.
Participate in process validation activities, including protocol development, execution, and report writing.
Support equipment qualification and commissioning activities for new manufacturing equipment or processes.
Participate in technology