Tyler Engle
Experienced Operations Leader | Aseptic Manufacturing
Pearland,TX
Summary
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.
Overview
10
10
years of professional experience
2
2
years of post-secondary education
4
4
Certifications
Work History
Manufacturing Supervisor
Lonza Cell and Gene Therapy
Houston, TX
05.2022 - Current
- Lead safety meetings and monitor compliance with site requirements and best practices.
- Supervise ongoing daily production.
- Perform on-the-floor coaching/mentoring in aseptic environment.
- Plan, organize and monitor resources to deliver efficient use of labor, equipment and materials.
- Monitor daily and weekly key performance indicators to maintain on-track status.
- Perform documentation reviews such as batch records and logbooks for accuracy and compliance.
- Conduct regular performance reviews, offering praise and recommendations for improvement.
- Lead improvement initiatives to advance operational efficiency and effectiveness.
- Manage staff hiring, training and development.
Manufacturing Supervisor
AGC Biologics
Boulder, CO
04.2021 - 05.2022
- Led safety meetings and monitored compliance with site requirements and best practices.
- Supervised ongoing daily production.
- Planned, organized and monitored resources to deliver efficient use of labor, equipment and materials.
- Monitored daily and weekly key performance indicators to maintain on-track status.
- Reviewed documentation such as batch records and logbooks for accuracy and compliance.
- Conducted regular performance reviews, offering praise and recommendations for improvement.
- Led improvement initiatives to advance operational efficiency and effectiveness.
- Managed staff hiring, training and development.
Training Compliance Specialist
Fagron Sterile Services (FSS)
Wichita, KS
07.2018 - 03.2021
- Developed and managed global Quality Management System (QMS), MasterControl, for multi-site organization.
- Developed and maintained onboarding program, training curricula and process qualifications for site personnel that are compliant with regulatory standards.
- Developed and maintained training compliance database, tracking all compliance activities and documents.
- Assisted with internal and external audits to confirm compliance with applicable laws and regulations.
- Maintained up-to-date knowledge of current and emerging training requirements.
- Reviewed, revised and updated training policies and procedures to confirm continual compliance with regulatory requirements.
General Manager
Noodles and Company
Parker, CO
12.2017 - 06.2018
- Managed daily restaurant operations
- Developed and maintained relationships with customers and suppliers.
- Managed restaurant budget implementations, employee reviews, training, and schedules.
- Implemented innovative programs to increase employee loyalty and reduce turnover.
- Trained and guided 25+ team members to maintain high productivity and performance metrics.
Training Coordinator and Fabrication Supervisor
Vortex Solids & Handling Components
Salina, KS
05.2014 - 11.2017
- Monitored training reports within learning management system for respective roles to promote initial and annual training completion.
- Worked with central management to identify, plan, align, and address training needs.
- Compiled training handbook and related course materials.
- Managed manufacturing staff of 3 leads and 20+ technicians.
- Managed hiring, training and scheduling.
- Supervised ongoing daily production.
- Collaborated with internal teams to streamline operations across materials handling, production, and shipping.
- Located and resolved problems with team production and performance to maintain consistent quality levels.
Education
Excellence in Management Certification -
Wichita State University - CMD
Wichita, KS 01.2019 - 10.2019
Youth Ministry -
Rhema Bible College
Broken Arrow, OK 08.2005 - 05.2007
Skills
Cell therapy
Drug substance manufacturing
Aseptic operations
Training and development
Technical writing/deviations
Quality/compliance
MasterControl/Trackwise/SAPCFR 210 & 211/USP 797 & 800/503BcGMP/GDPTeam building
Process improvement/six sigma
Written/oral communication
Industrial hygiene/safety
Risk/hazard analysis
CliniMACS Prodigy super user
Certification
Lean Six Sigma White Belt
Professional Highlights
- 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.
Timeline
Manufacturing Supervisor
Lonza Cell and Gene Therapy
05.2022 - Current
Manufacturing Supervisor
AGC Biologics
04.2021 - 05.2022
Excellence in Management Certification -
Wichita State University - CMD
01.2019 - 10.2019
Training Compliance Specialist
Fagron Sterile Services (FSS)
07.2018 - 03.2021
General Manager
Noodles and Company
12.2017 - 06.2018
Training Coordinator and Fabrication Supervisor
Vortex Solids & Handling Components
05.2014 - 11.2017
Youth Ministry -
Rhema Bible College
08.2005 - 05.2007