Ricardo Valdes

 Ricardo Valdes Maynard, MA 01754- /  787‑310‑5178  WWW : https://www.linkedin.com/in/ricardo‑valdes2296   /       Summary 8+ years of experience managing and leading teams in the industry, academia, and military. Extensive experience in project management, computer system validations, data integrity, and pharmaceutical IT systems (benchtop instrument software and enterprise systems) from engineering and quality assurance perspectives. Demonstrated effectiveness collaborating with colleagues in matrix organizations focused on stakeholder engagement and satisfaction. Diversity & inclusion advocate and mentor devoted to service and leadership. Skills Validation / Computer Systems Validation Software Documentation Data Integrity Risk Assessment Project Management Quality Assurance CAPAs Data Migration IT Systems and Systems Integration Experience Global Market Access – Innovation Catalyst Team (Tour of Duty) / Bristol Myers Squibb 09/2024 - Current Support various initiatives within the Strategy, Innovation & Capabilities team primarily working closely in advancing a Generative AI Global Value Dossier project. Work closely with other cross functional partners to ensure we actively support our BMS value by catalyzing innovation at scale that enables patient access at prices that reflect the holistic value of our medicines Manager, QC Instrument Lifecycle Engineer, CSV/ Bristol Myers Squibb 02/2023 - Current Lead execution of CSV/validation activities for qualification of new/modified/upgraded QC instrumentation Project manager for projects in the QC space related to benchtop systems Act as the project lead for qualification of QC equipment and its associated software Generate/execute Continuous Improvement (CI) initiatives Categorize and track progress against key project milestones, partnering with applicable stakeholders and external providers to assure overall project success and compliance Design, manage, and implement applicable validation documents, such as generic/custom software test scripts, User Requirement Specification (URS), Design Qualification (DQ), validation plans, Data Integrity (DI) assessments, risk assessments, configuration specifications, and qualification summary reports Champion qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/PAs) Provide quality oversight throughout each system’s lifecycle, assuring each system remains in a state of compliance Participate in an Instrument Lifecycle Community of Practice to include multiple commercial QC sites, with a focus on sharing best practices, identifying key risks, reviewing regulatory and inspection trends, and driving towards lifecycle/qualification standardization Own change controls impacting QC equipment/software Act as the liaison between Digital Plant (IT) and lab departments Perform periodic assessments/decommissioning Coordinate with external vendors for support Managing two employees to provide QC Laboratories operations support and complete project deliverables Drive continuous improvement working across matrix organization with IT, project managers, business process owners, subject matter experts (SMEs), and other key stakeholders Collaborate with business process owners to assure instruments, software, and equipment periodic reviews are completed in a timely manner to demonstrate systems have remained in a controlled, validated state and are fit for use Senior Quality and Labs Engineer/IT: Systems Development, Integration & Operations / Bristol Myers Squibb 05/2020 - 02/2023 Provided direct support in the Devens Digital Plant organization for the data integrity program Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and perform system installations, configurations, administrative and support functions including system validation lifecycles and training Provided support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment Support includes various instrument types such as ViCell, SoloVPE, Cary60, and Spectramax plate readers throughout the site which would include laboratory (R&D and GxP) and manufacturing buildings Provided local administrative support and liaison with global partners for the site quality systems (documentation system and quality management system) and quality control supporting applications (LIMS, Laboratory Execution System, NuGenesis, and Empower) This includes SOP driven activities which include, but are not limited to, application periodic reviews, user access reviews, and account administration Maintained accuracy within the asset management tool for hardware, such as benchtop PCs and servers Provided support for actions within the quality management system (Infinity) and support change requests, incident management, and problem management within Vitalize for assets that fall within the Devens Digital Plant Quality and Laboratory scope Supported creating, modifying, or archiving SOPs and Work Instructions, data flow maps, and application validation documentation as required Responsible for managing small to medium size projects within a highly matrix organization Collaborated with internal and external partners to provide compliant and technical solutions in a time sensitive environment Provided digital plant subject matter expertise (SME), to multi-function teams, advise operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies Oversaw two contractors to meet project deliverables and support IT operations. Sergeant / Army National Guard 11/2014 - 11/2020 Completed prestigious 3-week Army Basic Leadership Course (BLC) to become a Non-Commissioned Officer (NCO) Planned, executed, and delegated tasks to my soldiers (about 10) in order to proficiently accomplish every mission set by my superiors Set standards and provided guidance to lower enlisted to ensure all core values of the Army are upheld to the highest degree Conducted small and mid-scale training exercises to ensure the readiness and proficiency of my team, subordinates, as well as myself Trained alongside foreign military and governments to establish better relations and diplomatic understandings across the globe Maintained the safety and accountability of my team and fellow soldiers to ensure mission readiness, even at a moment's notice. C.O.R.E – Project Engineer / Commodore Builders 06/2019 - 05/2020 Provided full budgets and estimates throughout all pre-construction phases on different projects Collaborated with owners, landlords, architects, engineers, subcontractors and consultants to ensure the projects were set up for a successful construction phase Performed value engineering in order to efficiently reduce cost Negotiated and prepared contracts with sub-contractors and suppliers Maintained and provided weekly project reports to the project team tracking procurement, submittals, change orders, requests for information, and construction progress Closed out projects contractually and worked closely to ensure fast and efficient delivery of owner's building operation and maintenance manual Consistently networked to increase company's exposure and presence in the construction industry environment Led efforts to set-up, track, and document all procedures needed to mitigate impact of COVID-19 on every project. Assistant Project Manager / Merck & Co. Inc. Global Engineering Solutions 05/2018 - 08/2018 Assistant Project Manager during installation and qualification of Syringe Filling Line Inspection machine Supported project design efforts, providing innovative solutions that met business objective Ensured that deliverables conformed to Merck standards and practices, and were technically sound Provided technical guidance during project implementation, assured viability of technology in proposed configuration to meet customer, regulatory, and business needs Collaborated with contractors, suppliers and other engineers in the execution of the work Made sure project stayed on track and contributed to process and equipment safety reviews As a result, the project's schedule, budget, safety, and quality where all on target. Education and Training M.S. Engineering Management, Healthcare Systems Track Expected in 01/2025 John Hopkins University Certificate in: Bio manufacturing 05/2022 Worcester Polytechnic Institute B.S. in Chemical Engineering 05/2019 University of Massachusetts Amherst Certificates in: Project Management, Change Management, Crisis Management, Strategic Thinking, and Decision Making Harvard Business School 08/2018 Activities and Honors Community Soccer Coach Volunteer Cyclist for Cancer Fundraiser (my team raised over 120K) Certifications Six Sigma Yellow Belt OSHA 30 Foundations of GMP: Data Integrity and Computer System Validation Empower Application Administration NuGenesis Application Administration Languages English : Native/ Bilingual: Spanish : Native/ Bilingual:   References References available upon request.