Gerald Wallner, Mscit Email & Phone Number

Colorado, United States

Develops/maintains support structure processes with Infrastructure team and external department/contractor support. Supports manufacturing application security for threat response. Guide team in technical aspects of network lifecycle and implementation. Oversees technical aspects of manufacturing and laboratory networks, infrastructure, and application architecture. Articulates impact to and requirements of the manufacturing network as it relates to PLC, HMI/SCADA/DCS/MES, plant historian, facilities equipment, laboratory computer systems technology and applications. Presents technical findings to non-technical stakeholders at all levels of the organization. Determines system specifications and recommend most cost-effective technology to be implemented. Problem solves any network/infrastructure related issues impacting production or laboratory operations. Performs investigations of non-conformances related to infrastructure systems. Maintain archival and data retention processes for GxP systems. Collaborates with key stakeholders to define data and cybersecurity requirements that affect manufacturing automation systems. Contributes to continuous improvement programs to maintain instrument support within budget. Identify problems and inefficiencies in processes and methods, and propose and implement improvements. Provides oversight or participation all manufacturing infrastructure aspects of projects. Maintains procedures to meet GAMP guidance, GxP requirements, CFRs, and internal company policies.

Longmont, Colorado, United States

Work with Quality, IT, and Validation to support Quality computerized system lifecycle management activities from concept, development, validation, implementation and maintenance to retirement. Act as administrator for Quality computerized systems LIMS, Empower, and lab computerized systems. Plan and lead Quality IT projects lab instrument qualification. Author and review protocols, reports, SOP’s, investigations, non-conformance, CAPAs, and other records related to Quality computerized systems. Monitor Quality computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.

Boulder Colorado

Plan, design, and architect lab solutions for cGMP, Process Development and Research and Development Laboratory systems. Implement Align Enterprise standards and processes for support of multi-vendor platform solutions in a regulatory environment. Develop specifications for new systems implementations, network, domain, and data integrity architecture. Author SOP's, change control documentation, and configuration management documentation.

Boulder, Colorado

Global IT SME in planning, designing, and delivery of lab solutions in accordance with global IT Strategies. Manage KPI's, of 3rd party lab vendors and services, Drive short & long term project deliverables for laboratory solutions. Represent IT in proof of concept for technology direction and business strategy. Align Enterprise standards and processes for support of multi-vendor platform solutions in a regulatory environment. Perform impact analysis and change control design / execution to existing systems. Develop specifications for new systems implementations. Manage library of SOP's, change control documentation, and configuration documentation.

Boulder Colorado

Manage the Quality Assurance for testing Software, SDK, Firmware and Manufacturing QC for Sphero Connected Toys. Toy & Regulatory safety and compliance certification management for global distribution of products. FAMA and ILS compliance for Disney licensed products.

Colorado

Secretary Board of Directors, Registered Agent to the State of Colorado. Member TechStars 2011 Founders, Microsoft BizSpark member.

Project Management and QA Manager on Fortune Online for as few as 3 teams and as many as 5 different Scrum teams as ScrumMaster totalling nearly 50 staff. Implemented QA department for Webgames division. Handled resource managment, procurement, backlog coordination, release and change management, implmentation of bug tracking system, Sprint planning, reviews and roadmap gate processes.

Information Security / Physical Security Systems System OwnerEnterprise Document Management Systems QA System OwnerLearning Management Systems System OwnerIS Vendor Services Business Owner

Boulder

Apple / Compaq / HP Certified Technician Module level desktop, laptop, CRT, Laser printer repairs.Corporate Consulting

Indiana

Video production and investor video development for Dream Park Corporation.Audio and FX Design for Dream Park Corporation.Chief Composer Adventure Design CorporationFreelance Writer for Shadis MagazineAssociate Producer and audio engineering for Chroma Entertainment.

Louisville Air Hub

Supervised the loading of next day air jet aircraft.Ran Field Supervisor training program for new supervisors to teach them how to manage their first load crews.Chairperson RAMP Operations Safety Committee and KORE (Keeping our Reputation for Excellence) Teams.

Louisville

Started as an intern and worked up to camera operator, sound engineering, editing and associate producer. Projects included the Kentucky Lottery, Pledge funding campaigns, GE production support and Dimensions SciFi news program.

Clarksville Indiana

Assembled, maintained, repaired video gaming embedded systems, pinball machines, store management. Ran a training store of new electronic school graduates where the management training candidates were sent to this location for 30 days of training before graduating the management program and being assigned their own retail stores.Bally was the owner of Midway, Williams, Six Flags Parks, Casinos and numerous support subsidiary holdings.

Ms Computer Information Technology, Executive Management Information Technology, 4.0

GPA 4.0

Bgs, General Studies

Minors in Business Personnel Management; Communications Theory, Music

Boulder, Vc Accelerator