Tyler Engle

Disciplined Operations Leader with over 10+ years of experience; looking to build upon skills and tackle new responsibilities. Excellent knowledge of production processes and quality control standards. Adept at planning, directing and coordinating all manufacturing processes. Skilled at maintaining and communicating daily productivity to senior management.

Lean Six Sigma White Belt

• Site lead for implementing a global quality management system (QMS) – I was the project lead for two sites: leading the implementation of MasterControl. MasterControl is a digital QMS software, used by the FDA, for document control, administering training, managing investigations/CAPA, and process validation. We harmonized the SOP index from each site into a single governing system. By aligning our processes, we improved the ability to develop and manage training significantly.
• Training program development – I have developed comprehensive training course plans for multiple companies. Compliant with regulatory requirements (such as FDA and ISO 9001), I have built train-the-trainer/qualified trainer programs, operator simulations/qualifications, standard operating procedures (SOPs), and training assessments.
• Developed and implemented a database to track non-conformances – I collaborated with a computer programming team to develop a system that improved entering and tracking non-conformances in the manufacturing facility. By eliminating paper documentation, we improved data processing by 80%. Which in turn, results in metrics that are timely and effective.
• Established onboarding programs for new employees – I have developed onboarding programs that link all the necessary departments, such as HR, Quality, Safety, and Manufacturing together to streamline the new hire process. I improved employee retention and accelerated time-to-position.
• Developed a team for clinical trials – developed a cell therapy manufacturing team from the ground up.