I am seeking an experienced and dynamic Principal Project Engineer to join a groundbreaking Cell & Gene Therapy company based in London.

You will lead and execute Capital/Equipment Projects and play a key part in developing and implementing policies and procedures related to equipment, system, and process implementation. A hands-on approach is essential as you'll take ownership of capacity improvement projects and equipment reliability enhancements. Your role will be vital in coordinating and managing equipment and facility projects, ensuring they meet their scope, schedule, and budget.

This role will offer you:

• Work for a company offering a stimulating and rewarding environment where you can grow professionally, collaborate with industry leaders, make a significant impact, and contribute to the advancement of biopharmaceutical manufacturing.
• As an employee, you will have access to advanced equipment and systems, enabling you to work with the latest tools and technologies in the industry
• Exposure to numerous clinical projects which have the potential to save lives
• Exposure to high visibility from the senior leadership team
• Opportunity to join one of the most rapidly expanding biopharmaceutical companies in the UK

You will be responsible for

• Lead and oversee the execution of Capital/Equipment Projects, working closely with Validation
• Develop and implement documented policies and procedures for equipment, system, and process implementation
• Drive the introduction of new equipment and process improvements, diligently handling associated change documentation
• Take charge of capacity improvement projects and drive enhancements to equipment maintenance and reliability
• Effectively manage and track equipment and facility projects, conducting status meetings and mentoring staff from other departments
• Assist in procuring fit-for-purpose equipment and facilities for manufacturing, contributing to URS document generation
• Oversee matrix teams and indirect people management in the short term, with the potential for direct line management in the future
• Secure the budget for Facilities, Equipment, and Engineering expenditures.
• Maintain the facility, equipment, and processes in a qualified and validated state, prioritizing safety within GMP areas, including third-party engineers

You will bring the following

• Hold a degree in Engineering - BEng minimum or Equivalent
• Engineering experience in GMP pharmaceutical manufacturing, specifically in biopharmaceutical/ATMP/CGT/Cleanroom settings
• Previous hands-on working knowledge of various equipment, such as isolators, incubators, bioreactors, chromatography, tangential flow filtration systems, temperature-controlled units, and filter integrity test systems
• Knowledge of regulatory guidelines, including EU GMP/ICH/FDA/EMA/ISO/ISPE
• Experience in facilities manufacturing sterile products