Rob Russo

Experience

• 

  DPT Laboratories

  Jul 2010 - Nov 2010

  Validation Engineer

  • Generate and execute Qualification protocols/studies for sterile products, microbial controlled products (i.e. nasal sprays) for liquid and semisolid products. Reviewed and tabulated data. Supported the investigation activities related to deviations and generated final reports.• Performed Installation, Operational, and Process Qualification (IQ, OQ, PQ) on manufacturing and packaging equipment used to manufacture and package, liquid oral dose and semisolid topical products.• Document deviations, system failures, and corrective actions. If required, participate in resolution and validation of corrective actions.• Participate in cross functional teams to organize and plan equipment installation, start-up, and qualification activities.• Provide up to date status regarding project deliverables, equipment and the overall process qualification for the packaging.• Organized and lead activities associated with qualifying packaging lines used to fill and package liquid oral dosage products. Show less

• 

  Merck

  Feb 2011 - Apr 2012

  Deviation Management Investigator

  • Independently and as part of a project team, plan, design, and implement varied technical projects and studies requiring knowledge of engineering and/or the physical sciences.• Collect and interpret information and develop solutions to projects of various scopes under minimal supervision, guidance, and direction. Periodic checks and reports are utilized to review soundness of technical judgment and the status/schedule of the effort. • Review deviation alerts to assess the severity of the deviations encountered during the manufacturing process.• Perform investigation of deviation alerts to determine the root cause of the deviation and assess the impact that the deviation has on the product.• Collaborate with cross functional teams to drill down to the root cause and determine proper Corrective Actions / Preventative Actions (CAPAs).• Expertise and full application of sound scientific principles, theories, concepts, techniques, and project management skills, as well as a working knowledge of Merck methods, standards, procedures, and practices. Show less

• 

  Covex LLC

  Apr 2012 - Jul 2013

  Validation Engineer

  • Apply knowledge of 21 CFR Part 11 regulations to generate User Requirements, Functional Specifications and Test Scripts for stand-alone laboratory systems.• Generate Validation documents (IQ/OQ/PQ, URS/FS, HDS/SDS, Validation Plan, Implementation plan).• Coordinate with Subject Matter Experts (SME) to ensure the User Requirements, Functional Specifications, and Test Scripts encompass the robustness of the instrument.• Generate Validation Summary Reports to detail the results of test script execution• Conduct system assessments in a cGLP/cGMP environment.• Work independently with minimal supervision; provide up to date status deliverables; work in cross functional teams to complete validation tasks Show less

• 

  Pilgrim Quality Solutions

  Jul 2013 - Feb 2014

  Computer Systems Validation Specialist

  • Planning, scheduling, execution and leading validation project assignments• Design, development, validation, qualification, and implementation of new and existing products• Lead cross-functional project teams in the development and implementation of the validation plan and protocols• Review and approval of change controls supporting an integrated life-cycle approach to computer systems implementation and validation• Generate Validation Summary Reports to detail the results of test script execution• Work independently with minimal supervision; provide up to date status deliverables Show less

• 

  Bristol Myers Squibb

  Feb 2014 - Apr 2019

  • Leads one or more computer system validation efforts in support of GLP, GCP and/or GMP processes. • Work closely with software development teams, end users and internal regulatory compliance staff to ensure that validation activities are planned and executed in compliance with internal procedures. • Independently authors and reviews software development and validation deliverables. • Provides advice and guidance on applicable regulations and internal policies. • Conducts regulatory risk assessments. • Supports development of project cost estimates. • Participates in vendor audit activities. • Supervises junior staff. • Maintains close communication with stakeholders and team members to keep apprised of project status and timelines. • Reports project status to management. • Participates in continuous improvement efforts. Show less • Support computer system validation efforts for systems used in GMP, GLP and/or GCP processes ensuring adherence to applicable regulations and internal procedures• Perform assigned tasks including authoring and reviewing software development, testing and other computer system validation deliverables. • Work closely with validation lead to ensure that validation activities are planned and executed in compliance with internal procedures. • Maintain close communication with stakeholders and team members to keep apprised of project status and timelines. • Report project status to management. • Provide support for risk assessments and vendor audits. • Provide input to project cost estimates. • Participate in continuous improvement efforts. Show less

  • ITQM Associate Manager

    Jun 2015 - Apr 2019

  • Validation Analyst

    Feb 2014 - Jun 2015
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  GSK

  Apr 2019 - now

  • Runs the Computer System Validation program for two manufacturing facilities and QC labs; CSV Subject Matter Expert (SME) for the Hamilton site.• Manages budgets, resources and timelines, including contractor management and onboarding.• Conducts 1:1’s with direct reports and year-end performance reviews.• Escalates issues from direct reports to upper management, as needed.• Provides validation input/guidance for new capital projects.• Leverages prioritization and categorization skills to manage multiple projects simultaneously.• Reports metrics to upper management.• Collaborates with multiple departments on projects and deviations/CAPAs that impact the site. Show less Key Responsibilities:- Develop the site qualification plan and strategy, execution and implementation. Streamline testing requirements while maintaining regulatory and corporate compliance including creating new validation approaches for new equipment, processes, or to align procedures and standards- Develop, review, approve, and/or manage GxP system lifecycle documentation including Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Traceability Matrix, Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Validation Deviations and Qualification Summary Reports- Conduct System Compliance Risk Assessment- Generation, maintenance, technical review and approval of standard operational procedures for validation activities and site standard operating procedures.- Assess impact of changes to cGMP equipment/systems and methods and establish the applicable validation plan to ensure validated status following changes. Issue QSR confirming validation plan was successfully completed.- Support for internal audits, external global audits, regulatory agency audits and system compliance risk assessments as subject matter expert in assigned validation discipline.- Maintain up to date knowledge of validation requirements, practices and procedures and instruct other members of the site participating in validation studies- Work with other departments to troubleshoot equipment, process and validation issues.- Administer and create the computer validation program for the site, including the author/review/approval of computer Validation Master Plans, Process control IQ/OQ protocols, alarm acceptance testing, computer acceptance testing protocols and maintenance of computer systems- Acts as a Multi-Site Validation SME for computer systems.- Acts as Computer Systems SME during audits and assessments- Reviewing completed protocols for completeness, cGxP compliance and data acceptability Show less

  • Senior Manager GRC

    Oct 2023 - now

  • Computer Systems Validation Supervisor

    Jun 2022 - Oct 2023

  • Senior Validation Engineer

    Apr 2019 - Jun 2022