Senior Process Engineer

Michael Page; Barcelona; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading international pharmaceutical company in Barcelona seeks a Senior Process & Project Engineer to support the establishment of a new manufacturing and R&D facility. This role involves providing technical expertise for aseptic filling operations and leading process improvements. Ideal candidates will have experience in the pharmaceutical industry and be skilled in cross-functional collaboration, process troubleshooting, and optimization. This position offers a competitive salary and a chance to be part of a unique project.

Servicios

Competitive salary

Fixed contract

Opportunity for career growth

Formación

• Experience in aseptic filling operations and process improvement initiatives.
• Ability to collaborate with cross-functional teams and lead projects.
• Knowledge of regulatory compliance and industry best practices.

Responsabilidades

• Provide technical support for aseptic filling operations.
• Lead change management for process changes.
• Conduct root cause analyses for technical issues.
• Develop process control strategies to improve quality.
• Support regulatory inspections and audits.

Conocimientos

Technical expertise in aseptic filling operations

Process troubleshooting

Cross-functional collaboration

Root cause analysis

Process optimization skills

Descripción del empleo

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.