CLAYTON GALLAGHER
West End,NC
Summary
Results-driven Digital Manufacturing Engineer at Coty Inc, skilled in Power BI and process improvement strategies. Successfully managed MES data accuracy and led cross-functional teams to enhance operational efficiency. Proven leadership in project execution and stakeholder engagement, ensuring compliance with cGMP and ISO standards while driving impactful change.
Overview
10
10
years of professional experience
Work History
Digital Manufacturing Engineer
Coty Inc
09.2018 - Current
- Create digital tools and dashboards in PowerBi to track key metrics (KPI’s)
- Acted as the site subject matter expert for PowerBi.
- Demonstrated expertise in DAX and data cleaning techniques.
- Tracked MES data in SQL database using PowerBi to ensure accurate reporting
- Collaborated with line teams to enhance MES accuracy through targeted initiatives
- Identify and reduce losses through root cause analysis (5Y, Fishbone, 6W2H, Pareto, FMEA, A3)
- Present improvement projects to senior stakeholders
- Authored project charters and CAPEX justifications, detailing design improvements and specifications
- Manage and track project execution through MOC process
- Start-up equipment and own equipment and process qualification (CQV)
- Own validation KPI’s and create documentation
- Responsible for phase sign offs and timeline adherence
- Create standard work and define best practices
- Work with cross functional teams to launch new initiatives
- Support line trials, set success criteria
- Provide financial and planning impact
Regulatory Affairs Specialist
Integra LifeScience
07.2017 - 09.2018
- Performed regulatory affairs activities ensuring site compliance with FDA 21 CFR 820 and other domestic and international regulations, supporting successful audits and product approvals
- Managed design history files (DHF), risk management files, and product technical files to facilitate regulatory submissions and ensure product integrity
- Assisted during BSI MDD audit to confirm adherence to regulatory standards, contributing to successful certification outcomes
Associate Quality Engineer
Mammotome
06.2016 - 12.2016
- Developed risk management reports and utilized risk management tools (FMEA, Pareto) to ensure compliance with BS EN ISO 14971:2012.
- Analyze and report post-market complaint trends to senior leadership
- Supported customer complaint investigations to identify root causes and improve product quality.
- Supported FDA QSIT audit and ISO 13485:2012 recertification audit
- Improves products through implementation of quality management policies, procedures, specifications, test methods and measurement systems.
- Provides support for product reliability assessments and reliability test plans.
- Develops risk management plans, reports, and utilize risk management tools such as FMEAs.
- Applied systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues collaboratively.
- Participates in and assists with the coordination of elements of investigations regarding customer complaints.
- Ensures compliance of project activities to appropriate regulations and standards (FDA, ISO, EN).
- Partners with Manufacturing, Marketing, Regulatory and Engineering functions to define requirements for new product development.
- Supported process capability studies and special studies to enhance control and reduce total quality costs.
- Uses quality tools and practices to assist in the establishment of approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies.
- Supports the validation of product designs, manufacturing processes, equipment, and procedures required for the production and delivery of finished product.
- Supports the administration of project management and design control.
Education
B.S. - Chemical Engineering
The Ohio State University
Columbus, OH12-2015
Skills
- Excel and Power BI
- Project management
- Data analysis tools
- MATLAB and JMP
- SAP S/4HANA
- Quality standards
- Team leadership
- Training and mentoring
- Process improvement
- Stakeholder management
- Manufacturing automation
- Documentation management
Technical And Professional Qualifications
Excel, PowerBi, PowerPoint, Outlook, ETQ, Visio, Access, Minitab, Matlab, JMP, SAP (S4/HANA), Serve as site’s PowerBi and Excel SME., Experienced working with complex data structures, and disparate data sources., Experienced with SAP S4/HANA., Experienced working in cGMP and ISO environments (consumer beauty and Medical Device)., Led teams as part of improvement events., Trained and mentored new process engineers., Managed and coordinated new initiatives with external stakeholders., Led new equipment startup., Authored and trained others on new processes and systems.
Timeline
Digital Manufacturing Engineer
Coty Inc
09.2018 - Current
Regulatory Affairs Specialist
Integra LifeScience
07.2017 - 09.2018
Associate Quality Engineer
Mammotome
06.2016 - 12.2016
B.S. - Chemical Engineering
The Ohio State University