Senior Process Engineer

We are seeking a
Senior
Process&Project Engineer
to join a pharmaceutical manufacturing facility located in Vallès Occidental. The role involves supporting aseptic filling operations (technical support, optimization, improvement and projects).

Detalles del cliente

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.

Descripción de la oferta

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.

Perfil del candidato

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.

Oferta de empleo

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.