Ryan Clarke
Vancouver
Summary
Industrial biochemistry graduate from the University of Limerick. 7 years' experience in GMP manufacturing environment.
Extremely organized with the ability to work both independently of own initiative or as part of a cross functional team, demonstrating the motivation and multi-tasking abilities required to meet demanding deadlines while maintaining the highest of standards. Combines a professional and confident approach with excellent interpersonal skills and can communicate concisely at all levels.
Overview
7
7
years of professional experience
Work History
Process Engineer
STEMCELL Technologies
11.2022 - Current
- Enhance product quality by collaborating with cross-functional teams to address design and production issues.
- Collaborate with Process Development and R&D to develop and implement scalable, validated, robust and reliable manufacturing processes and process control strategies.
- Oversee and support process overhaul team, support equipment design and documentation, evaluation, selection, and approval of third-party equipment as required by applicable GMP manufacturing regulations.
- Support product continuity by supporting NCR closure, MFG tech support, SAP recipe building.
Validation Specialist
New Beta Innovation
12.2021 - 10.2022
- Prepared and reviewed commissioning, qualification and validation documents for equipment, utilities, facility and processes with focus on cGMP compliance. Included but not limited to- URS, DQ, FDS, FAT/SAT, IOQ, PQ, validation plan, risk assessment, validation summary report, SOPS cleaning validation , computer system validation (CSV), requalification etc
- Supported maintaining the equipment validation activities with user departments. Provided oversite to validation activates execution within user departments
- Supported and collaborated execution of validation activities with users department.
- Supported and maintained track record of all audit trail review and computerized system management activates for all GMP systems.
- Support and review validation documents and ensure compliance to regulations
Operations Manufacturing Shift Team Lead
Sk Biotek Ireland
04.2020 - 10.2021
- Directly responsible for man-management of all manpower assigned to the manufacturing plant on a given shift. This included supervision on a day-to-day basis, training and communication, assignment and prioritization of work, delivery of objectives, performance management including development of direct reports, resolution and escalation of grievances and disciplinary issues. Had 8 direct reports.
- Enhanced team productivity by implementing efficient shift schedules and task delegation.
- Streamlined communication between shifts through detailed handover notes and regular team meetings.
- Provided comprehensive training to new employees, ensuring their successful integration into the team.
- Responsible for providing engineering support to the assigned plant to ensure safety, compliance and throughput goals are met and that troubleshooting of processes and plant related issues are completed in real time.
- Reported and investigated any safety or environmental incidents raised on the shift. Coordinate resolution or escalation of unsafe conditions or near misses that are observed.
- Accountable for housekeeping and audit preparations in assigned area.
- Reported and investigated batch deviations or quality issues on the shift and escalates issues promptly to the quality department.
Process Engineer
Sk Biotek Ireland
05.2017 - 04.2020
- Optimized manufacturing processes by implementing continuous improvement initiatives and lean methodologies.
- Reduced production downtime by conducting thorough root cause analyses and implementing corrective actions.
- Collaborated with cross-functional teams to improve product quality, resulting in increased customer satisfaction.
- Developed process control strategies for optimizing equipment performance and reducing variability in production output.
- Implemented standardized work instructions, enhancing operator understanding of critical tasks and improving workflow consistency.
- Provided technical support for troubleshooting equipment issues, maintaining plant reliability and minimizing operational disruptions.
- Supported new product development efforts through scale-up activities from pilot-scale testing to full-scale production implementation.
- Identified bottlenecks in the production line through capacity analysis studies, increasing overall throughput rates as a result.
Education
Bachelor of Science - Industrial Biochemistry
University of Limerick
Limerick Ireland05.2017
Skills
- Continuous Improvement
- Team Collaboration
- Critical Thinking
- Process Improvement
- Process Development
- Manufacturing Processes
- Process Validation
- Equipment Design
- Process Optimization
Timeline
Process Engineer
STEMCELL Technologies
11.2022 - Current
Validation Specialist
New Beta Innovation
12.2021 - 10.2022
Operations Manufacturing Shift Team Lead
Sk Biotek Ireland
04.2020 - 10.2021
Process Engineer
Sk Biotek Ireland
05.2017 - 04.2020
Bachelor of Science - Industrial Biochemistry
University of Limerick
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