Ehren Layton Email & Phone Number

Saint Paul, Mn, Us

St Louis Park, Minnesota, United States

Global CSV role supporting sites in North America, France, and Germany for all GxP computerized system validation projects. Focus on laboratory systems remediation projects while seeking process and regulatory application alignment across all sites. Expanding awareness of CSA methodologies and importance of traceability related to data integrity fundamentals. Supports supplier, internal, third party, and regulatory audit initiatives. Collaborates with IT, Lab Operations, and Engineering to ensure system consistency and compliance.

Greater Minneapolis-St. Paul Area

Headed the CSV group which was responsible for the lifecycle management of all GxP computerized systems across the QC labs and Production manufacturing areas at this biopharmaceutical plant. Duties included approval as well as authorship of all CSV deliverables (Validation Plan, Requirements Specification, Risk Assessment, Part 11/ERES/GxP Assessment, Design and Configuration Specification, IOPQ Protocols, and Test / Validation Reports) through application of local and global procedures. Supervised permanent and temporary CSV engineers.Application of ISPE GAMP 5, 21 CFR Part 11, and Annex 11 guidances.

Greater Minneapolis-St. Paul Area

Performed and managed informatics validation projects, system administration tasks, and general IT support . Plan, manage, and execute laboratory computer system validation projects in a regulated medical device environment across multiple labs and sites. This included authoring and review of all CSV deliverables (Validation Plan, System Requirements Specification, Risk Assessments, Design and Configuration Specifications, Test Plan, Test Report, and Validation Reports). System administrator for multiple laboratories which includes LIMS, CDS, ELN, SDMS, and other COTS software systems. Utilized leadership skills in project manager role for multiple software implementation projects including prioritizing, scheduling, and reporting progress using Microsoft Project. Highly skilled at working independently to gather and translate business requirements from system stakeholders. Adept at translating laboratory workflows into informatics solutions through communication with SMEs and efficient knowledge of the lab.

(Cima Labs, Inc.) In Brooklyn Park, Mn

Split management role in charge of Stability and business owner for site lab informatics (LIMS, ELN, & CDS). Oversight of commercial and development stability programs worth $500K annual revenue. Improved analyst on-time test reporting to zero time deviations under my leadership. Designed Stability KPI metrics system for accurate resource reporting and allocation. Expert in authoring and review of LIR, OOS/OOT investigations, deviations, CAPAs, and change control records. Demonstrated ability in hosting partner and regulatory agency audits. Led implementation of a validated ELN system that transformed the lab to fully paperless. Active data integrity champion that worked with internal partners to establish new procedures and expectations for site analytical data. Researched and implemented behavioral interview program as a group effort to the benefit of the entire department.

Brooklyn Park, Mn

Primary role as stability testing analyst with supervisory responsibility. Led continuous improvement group focused on minimal note-booking requirements for reduction in notebook lifecycle. Authored laboratory investigations and deviations in Trackwise system. Tested controlled substance combination products per DEA regulations. Business lead for design and implementation of a global LabWare LIMS system. Owned local LIMS instance. Pioneered the smart test LIMS analysis model, which focused on capturing as much information as possible directly into LIMS at the benchtop.

Brooklyn Park, Mn

Performed method development on oral solid dosage product. Developed and validated small molecule HPLC dissolution method for ANDA submission. Improved leadership skills through mediating of Analytical Department weekly meeting. Participated in safety program as lab SME. Created entry-level progressive training program for lab that improved training effectiveness and compliance.

Eden Prairie, Mn

Second shift supervisor for the QC lab. Performed testing on raw materials, intermediates, and finished tablet product. Executed line check clearances in manufacturing as part of the Quality team. Established cleaning swabbing program for manufacturing. Executed method transfer protocols in the QC lab.