Wil Gutierrez Email & Phone Number

Bothell, Washington, Us

Fort Lauderdale, Florida, Us

Supporting CSV activities related to combo medical device. Modifying current manufacturing process and equipment to incorporate COTS and custom applications for controlling real-time data collection, and enhance ALCOA capabilities during Production.

Raleigh, North Carolina, Us

Timrå, Se

Providing validation expertise for Microsoft Dynamics 365 implementation

Greenville, South Carolina, Us

Direct the implementation of Abbott StarLIMS and Lonza MODA-ES applications for QC and Microbiology departments.

Aliso Viejo, Ca, Us

Member of R&D IT department for Phase III clinical trial data collection implementation. • Validation lead for the development and implementation of clinical data systemso Veeva CTMS; Clinical Ink; Endpoint IRT• Provide guidance and expertise on electronic data management compliance practices

Durham, Nc, Us

Represent Clarkston Life Sciences group • Collaborate with multi-functional teams representing: Quality Assurance, Validation, IT, Operations, System Owners, and End-Users• Provide guidance and expertise on electronic data management compliance, deliverables, and best practices• Client(s):o Boston Biomedical – Phase III clinical trial support

Bethlehem, Pa, Us

Computerized Systems Team member for remediation efforts affecting electronic data management and data integrity. Primary focus on laboratory systems and applications. • Collaborate with multi-functional teams representing: Quality Assurance, Validation, IT, Operations, System Owners, and End-Users• Provide guidance and expertise on electronic data compliance practices, deliverables, and tasks• Assess compliance risk associated with data management, security and access controls, and business processes

Toledo, Oh, Us

Program manager for global electronic data management (EDM) and compliance practices - report to executive leadership. Primary representative within Quality for computerized systems validation and qualification. Support enterprise software development projects; including: LIMS, ProCal, NAMSA Connect (web portal). Develop and execute training on CSV, EDM, and general validation practices. Provide guidance to the organization concerning industry best-practices. Partner with IT, Operations, Engineering, Sales and Marketing to identify synergies, and ensure integrated/optimized and compliant business practices.

St Louis, Missouri, Us

Lead cross functional teams to ensure compliance with industry and global regulatory standards. Provide validation support/representation during regulatory audits with various global regulatory agencies. Develop client relationships. Perform needs assessment and requirements analysis to ensure client needs are understood and can be resolved. Promote BWDG services and support as part of a collaborative approach with current and prospective clients.

Minneapolis, Mn, Us

Legacy software remediation. Investigate, assess, author, review, and approve deliverables to support verification and validation of computerized systems.

Author, implement, and provide training for policies and procedures governing the development and control of computerized systems used throughout the enterprise.Provide direction and oversight to cross-functional teams on validating systems and toolsSubject-matter-expert on industry best practices and regulatory requirements affecting software development, acquisition, and change control.Lead and direct the execution of Master Plans governing remediation activities as part of corporate Quality initiative

Minneapolis, Mn, Us

Provide test case development and execution expertise to the Corporate Test Group for computerized systems validation.

Warsaw, Indiana, Us

Support the Quality department to resolve a backlog of Complaints following a site integration and migration to a new Complaint Management system (Enovia).

St. Paul, Minnesota, Us

Developed and executed validation deliverables related to site manufacturing. Scope includes all equipment, tooling, fixtures, processes, and procedures affecting all Atrial Fibrilation products. Artifacts include: Equipment Specifications (Requirements and Design), IQ, OQ , PQ , and Reports. Execution of qualification protocols, deviation reporting, change requests.

Minneapolis, Minnesota, Us

Provide support to Quality Engineering for rapid development and deployment of next-generation atherectomy product.Facilitate the development of Risk Assessment documentation: DFMECA, PFMECA, PHA. Review test methods for design validation; test protocols for biocompatibility, sterility, and packaging. Successfully completed full product development lifecycle and commercial launch - September 2009.

2500 Valby, Dk

Develop and implement computerized systems validation project plans and deliverables.Manage the activities of 3 consultants and 1 direct report as they relate to CSV projects.Provide guidance and direction in the effective execution of CSV projects affecting GxP operations, Laboratory Information Systems (LIMS), IT/networking infrastructure, Document Control, and Change Management systems.

Marlborough, Ma, Us

Perform validation of automated systems and assess Legacy Software systems for compliance to 21 CFR Part 11.

San Diego, Ca, Us

Direct the development and implementation of an ISO 13485 compliant Quality System for the Enterprise.Primary focus on software development (internal and customer facing), production automation, ERP (JDE), CRM, and IT infrastructure.Provided guidance and training on the principles of validation, as well as development and execution of SDLC deliverables.

Abbott Park, Illinois, Us

Provide guidance and support to Production, Manufacturing, and Equipment Engineering subject matter experts (SMEs) for the development, implementation, and execution of validation lifecycle activities.Design procedures and test methods which comply with business, Regulatory, FDA, and industry best-practice guidelines: FDA 21 CFR Part 820 and Part 11; ISO 14971 and 13485; cGMP; GAMP4; ASQ; IEEE.

Reston, Va, Us

Supported multiple projects for Pharma, Government, and Department of Defense (DoD).

Ca, 92121, Us

Determine specifications for the design, testing, and implementation of new manufacturing equipmentDevelop and execute protocols used for testing materials used in packaging, manufacturing, and distribution in accordance with ISTA, ASTM, ISO, and GMP standards and regulations.Cross-functional Core Team member

Arlington, Virginia, Us

B Co. 2/504 PIR, 82nd Airborne Div., Fort Bragg, NC

B.S., Business And Information System

Associates Degree, General