• 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.

?? What We're Looking For:

• Bachelor's degree in Chemical or Mechanical Engineering, or a related field.


• Minimum of 5 years of experience in aseptic manufacturing operations in the pharmaceutical industry


• Strong knowledge of aseptic processing principles. Equipment and utilities, cGMP regulations, and regulatory requirements (e.g., FDA, EMA).


• Experience with aseptic filling equipment and processes, such as isolators, filling machines, lyophilizers, and sterilization.


• Experience with aseptic formulation and cleaning processes , equipment and utitilities needed such as vessels, autoclaves, visual inspection.packaging


• Proficient in data analysis and statistical tools for process monitoring and optimization.


• Excellent problem-solving and troubleshooting skills, with the ability to identify root causes and implement effective corrective actions.


• Strong communication and collaboration skills, with the ability to work effectively in a cross-functional team environment.


• Detail-oriented, with a commitment to ensuring compliance and delivering high-quality results.