International pharmaceutical company with a new plant in the area of Barcelona
Project with high impact in the company and visibility
Are you ready to take part in building something new from the ground up? 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. In addition, the company will conduct R&D activities and manage technology transfer and FDF imports into EU markets from third countries.
What You'll Be Doing:
* Provide technical expertise and support for aseptic filling operations, including process troubleshooting, optimization, and improvement initiatives.
* 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.
* Lead change management system for process changes or new processes and equipment.
* 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.
* Perform product complaint assessments and or investigations, and other related post-market surveillance activities.
* 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.
* Collaborate with cross-functional teams to develop and implement process improvements, ensuring optimized and efficient manufacturing operations.
* Utilize Lean Production System elements and methods to continuously improve Engineering tactical business processes and procedures.
* 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 transfer activities from development to commercial manufacturing, ensuring successful scale-up and process validation.
* Support regulatory inspections and audits by providing technical expertise and documentation.
* Foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements, and best practices related to aseptic processing.
* Provide technical training and guidance to manufacturing personnel on aseptic techniques, equipment operation, and process controls.
What We Offer:
* A unique opportunity to be part of the launch and growth of a brand-new pharmaceutical facility in Spain.
* Collaboration with experienced professionals and strategic partners across Europe's pharmaceutical industry.
* Competitive salary, aligned with your skills and experience.
* Fixed contract.
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