Senior Process Engineer

• 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.

• 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.

• 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.

Michael Page