Luis Valentin Email & Phone Number

Aguada, Puerto Rico

Puerto Rico

Añasco, Pr

Special two years assignment as Supplier Quality Assurance engineer. Supporting a vendors consolidation project for J&J Vision.Under the Quality Engineering Department provides Computer Systems Validation site support. Supporting data integrity remediation activities for manufacturing, utilities and laboratory applications. Providing CSV support to electronic device history implementation (eDHR) using the SAP application. Site Lead for J&J CSV Policies implementation. Leading contractors to support remediation of gaps identified by corporate QA. In charge of hiring contractors and manage budget. Managed $1.5M for capital improvements of computerized systems supporting labs and operations. Johnson and Johnson Vision/Abbot Medical Optics manufactures intraocular cataract lenses and equipment.

Humacao, Puerto Rico

IT Operations and Compliance Support Systems: New roles managing compliance area support within the IT Department. Also, providing CSV support to manufacturing, laboratory and business applications. Direct supervision of two direct reports and project's contractors.IT Manager-Manufacturing Systems and CSVIn charge of the computerized systems validation projects at the site that support the manufacturing operations. Working under the IT Department and reporting to the IT Director. Participate in computerized systems suppliers vendor audits, provide support during FDA/EMA or any other external audits; validation of computerized systems; review of CSV documentation; CAPA management activities. Interview and select contract resources, participates in department and projects budget preparation. Support all new system development lifecycle activities for manufacturing systems implementation, business and enterprise applications implementation at the site including (i.e. OSI PI, Discoverant, Robar Labels software). Implementing GAMP 5 practices at the site to align with corporate directives. Manage contractors as needed as part of the assigned projects.

Juncos, Pr

CSV Subject Matter Expert supporting the Quality Department. Evaluating, and developing CSV documents for the automated process supporting the manufacturing and quality systems at the site. Providing support to current projects in order to comply with Medtronic's policies in CSV.

Barceloneta, Pr

Provided support to the Provox to Delta V migration project. Executing IQ protocols to confirm proper instruments comunication with the Delta V application.

Las Piedras

Business development activities for JC Automation in the areas of automation, computerized systems validation, IT and regulatory compliance.

Juncos, Pr

Worked under the Quality Department and reporting directly to the department head, in charge of the implementation of the software controls methodologies for the Medtronic CRDM business at Juncos; also part of the team in charge of the development of the regional methodology for MPROC (Villalba, Humacao, Juncos). Participated in the development, training and implementation of the Computer Systems Validation Methodology and the System Development Lifecycle methodology for the MPROC sites using industry regulation standards and the GAMP 5 methodology. Development and execution of validation protocols for manufacturing equipment and for systems implemented by the IT Department. Ensuring compliance of manufacturing engineers with disaster recovery plans, security controls and software controls practices. Worked with the implementation of the Computerized Systems Validation methodology as part of the Quality Improvement Project (QIP) for Process Validation. Managed assigned corrective and preventive actions at the site.

Performed business development and project management activities, mainly within the computer systems validation and automation fields. Offered placement of subcontracted personnel within the life science industries. In charge of projects management in different areas of validation, documentation development and equipment qualification and computer systems validation within the following companies: Amgen, Lifescan (sub-contract under Invision Engineering), Invision Engineering Company

As a contractor, supported the site in the definition and execution of tasks required for the site transition to a new buyer. Evaluated the automated computerized systems at the site; established the site project scheduled to integrate the activities of the associated departments. Look for and brought to the site the required contractors to modify the systems that were to be sold to guarantee that no references to Bristol Myers Company and products were left in the system as well as to remove recipes and clear databases from any remaining information. Participated as part of the management leadership team meetings to evaluate and follow up on the required activities and coordinate inter departmental activities.

Managed the Computer Validation section and the Automation section under the Information Management (IM) Department. In charge of the quality systems, computer systems validation and automation functions at the site. Responsibilities also include manufacturing support directing the CIMS (MES) application and hardware support sections. Total of 11 persons organization. Provide developmental opportunities to personnel, performed employee reviews and submit promotion recommendations.Led IM site closing activities: system retirement and head count reduction. Assure compliance with BMS CSV guidelines and FDA regulations. Performed project management activities for projects developed following automation development standards under the GAMP 4 guides for development of new site applications. Supervisory responsibility included hourly and exempt personnel within the identified areas. Identifying areas of opportunities to improve process and provide better customer service. Developing personnel under my direct supervision by providing adequate training on identified areas. Contracting and supervising computer validation and automation contract personnel to support site projects.Member of the site change control board. Reviewing the GMP impact of process changes impacting the manufacturing operations and approving for execution. Interview and contract vendors to provide validation services to the IM department at the site. Review of validation documentation, both internal and from contracted personnel (i.e. URS, FRS, DS, VP, qualification protocols and summary reports). Conduct vendor audits for computerized systems providers. Supporting the CARs development and budget estimating; hiring of validation contractors for validation projects.

Provided project management support to the IM department at the MSE Project Expansion at BMS Manati site. Supported the validation of a $200M site expansion. The new facilities are a state of the art parenteral facility for manufacturing of parenteral and biologics products. In charge of CSV management of three main projects: lyophilizers (4 units), Rockwell Process Automation System, Autoclaves (2) and Parts Washer (2). Supervising approximately 15 contracted resources. Deliveries include URS, Validation Plans, Design Specifications, IOQ protocols, IOQ executions, final summary reports and traceability matrix. Responsibilities include coordination of activities with several department and resources in order to effectively comply with projects due dates. Request of proposals, project scope definitions, generation of requisitions for contracted services using SAP; payment approvals and budget tracking.

Worked in the Information Management Department. My duties included the following:Project management to coordinate all activities needed to successfully complete the validation project on the estimated time.Implementing the Computer Systems Validation Methodology at the site. Manufacturing site is for parenteral, oncology and oral solid dosage form products.Perform the computer validation of application software and manufacturing systems at the site following the System Development Life Cycle approach (SDLC). This includes the development of the Validation Plan, Project Schedule, User Requirements Specifications (URS), Functional Design Specifications and IQ, OQ and PQ protocols.Negotiating support services from validation support companies and effectively managing their assigned personnel.Validate and implement the Isotrain software version 5.0.5 at the Mayaguez site.Experience with the following equipments: Lyophilizers, Data Collection Systems, Building Management Control Systems, Lakso Filler Machines, Skinetta Cartoner Machines, Kikusui Tablet Press machine and Chase Logeman Filler Machine.FAT support activities; as part of a trip to Japan, I was responsible of providing a 21 CFR Part 11 presentation to the plant personnel at Otsuka Pharmaceutical Co., LTD.Participated with the development of Regional SOP's for Computer Validation aimed to standardize the practices across the four BMS sites of Puerto Rico.

Worked in the Technical Services Department during the consent decree. My duties included:Project management to coordinate all activities needed to successfully complete the validation project on the estimated time.Perform the computer validation of application software and manufacturing systems at the site following the System Development Life Cycle approach (SDLC). This includes the development of the Validation Plan, Project Schedule, User Requirements Specifications (URS), Functional Design Specifications and IQ, OQ and PQ protocols.Negotiate support services from validation support companies and effectively managed their assigned personnel.Led the implementation for the Puerto Rico (Manatí and Las Piedras) sites of ISOtrain Training Management System.

Worked within the QC/QA Department. Started as Validation Specialist, then moved to Sr. Validation Specialist and end as a Sr. Computer Systems Validation Specialist. Responsible for validation of parenteral products, bulk process, oral solid dosage process, equipment qualification, cleaning validation and computerized systems in the plant, outside contractor management and general validation activities within the manufacturing site. Main responsibilities as computer validation specialist were:In charge of the computerized systems validation in the Barceloneta facilities including the change control program. The site includes three bulk manufacturing plants and two finished product facilities for penicillin and cephalosporin products, including parenterals.Conducted software validation of in-house programs and outside vendor programs.Key member of the Electronic Records and Signature team. This team was aimed to guarantee that the Barceloneta facilities comply with all the requirements of the 21 CFR part 11 of the cGMP's.Assigned as Y2K leader for manufacturing systems remediation.

Manati, Pr

Worked in the Technical Services Department during the consent decree. My duties included:• Project management to coordinate all activities needed to successfully complete the validation project on the estimated time.• Perform the computer validation of application software and manufacturing systems at the site following the System Development Life Cycle approach (SDLC). This includes the development of the Validation Plan, Project Schedule, User Requirements Specifications (URS), Functional Design Specifications and IQ, OQ and PQ protocols.• Negotiate support services from validation support companies and effectively managed their assigned personnel.• Led the implementation for the Puerto Rico (Manatí and Las Piedras) sites of ISOtrain Training Management System.

Under consent decree environment, my major duties included: Preparation of the Annual Product Reviews, perform statistical and trend analysis, issue recommendations to the upper management concerning to the evaluation of the manufacturing processes if the data demonstrates that a problem may exist, attend consultants during internal audits, assist management during FDA inspections.

Mba, Technology Management

Bs, Industrial Engineerng

Mba Degree, Technology Management