Key Responsibilities:

• Lead cross-functional design reviews of single-use bioreactor platforms to identify areas for improvement, standardization, and optimization.
• Enhance the layout, installation, and usage of single-use assemblies to improve aseptic handling and reduce operational risks.
• Drive design improvements and modifications in key areas, including:
  • Media feed and waste management
  • Aseptic connections and disconnections
  • Assembly design and sampling processes
  • Procedural controls and operator training
• Oversee the qualification and validation of new and existing process equipment used in conjunction with single-use systems.
• Develop and execute qualification protocols to ensure compliance with Good Manufacturing Practices (GMP).
• Document all qualification activities using electronic documentation systems to maintain GMP compliance.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to resolve discrepancies and implement corrective actions.
• Lead initiatives to optimize processes for scalability, robustness, and reliability of single-use technologies.
• Contribute to the development of procedural documentation, training materials, and best practices for single-use systems in the manufacturing process.

• Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, or a related discipline.
• Minimum of 7 years of experience in biopharmaceutical manufacturing, with a focus on upstream processes and single-use technologies.
• Expertise in process design, equipment qualification, and validation within a GMP environment.
• Hands-on experience with single-use bioreactor systems and related process equipment.
• Strong understanding of aseptic processing principles, including media feed, waste stream management, and aseptic connections.
• Proficiency in using electronic documentation systems for authoring and managing qualification protocols.
• Demonstrated ability to lead cross-functional projects from design through to implementation.
• Excellent problem-solving skills, attention to detail, and proactive risk management.
• Strong communication and presentation skills for effective stakeholder engagement.

• Experience with process optimization and design improvements for single-use technologies in large-scale biopharmaceutical manufacturing.
• Familiarity with the qualification of equipment used in single-use system integration.
• Experience in developing and reviewing procedural controls and training programs for manufacturing operations.