Hani Sawiris Email & Phone Number

Bethlehem, Pa, Us

Experience with numerous platforms and technologies such as Veeva, ComplianceWire Learning Management System, Asana, Monday.com, HP ALM, qTest, Res_Q Validation Platform, SharePoint, DocuSign, AdobeSign, Okta, CyberArk products, Amazon Web Services, Microsoft Authenticator, and other Microsoft Products.Overall, provided IT Quality Assurance, Inspection Readiness, Compliance, Data Integrity, Risk Management, and Computer System Validation Consulting Services to 20 companies and institutions, primarily regulated by the FDA. Programs, Projects, and experience include the following:- Performed GMP Technical Writing, GMP Investigations, Root Cause Analysis, and CAPA training for a pharmaceutical manufacturer. The feedback of the trainees was almost 100% positive. They felt the training was practical and could be applied in their day-to-day job.- Established a GxP data integrity governance program for life sciences clients which include developing a data integrity plan, procedures, data integrity assessment form, and an overall data integrity project plan. This improves the data integrity posture of the clients for the numerous GxP systems they manage.- Provide Inspection Readiness in preparation for upcoming FDA BIMO, Pre-Approval and other regulatory inspections.- Conduct software vendor audits for numerous life sciences companies.- Lead the development and review of SDLC / Software Testing documentation, Policies, Standard Operating Procedures, and Work Instructions.- Author GxP Data Integrity Plans, SOPs, and Data Integrity Assessment Forms, Account Access Request and Review SOPs and Forms, GxP Infrastructure and Software Tool Qualification SOPs, GxP System Retirement SOPs, and SDLC SOPs.- Manage various Deviation and CAPA Management programs (Corrective and Preventive Actions).- Review and approve IT / System related Change Management Requests.- Conduct Periodic Reviews of various GxP systems to confirm their validated state.

Rahway, New Jersey, Us

• Designed and implemented a risk-based framework to drive organizational actions for deviations and non-conformities. The process has enabled effective and efficient response activities and documentation thereby reducing residual risk.• Led corporate IT governance bodies to evaluate and implement risk-based changes to the company’s procedures, standards and policies and improve the company’s security, disaster recovery, and business continuity posture. • Developed and implemented SOPs with the focus on life cycle integration resulting in increased compliance by over 50 percent over the past 12 months.• Led budget optimization for a global IT Compliance program to drive an integrated framework for the organization by leveraging contractors / offshore resources. Reduced cost by 60% in the last 2 years while improving the company’s compliance posture.• Implemented various innovative platforms to enable the global IT compliance, deviation and CAPA management programs. The result was effective data analytics and trend analysis.• Managed GxP audits, periodic reviews, and inspections across the company proactively enabling the identification of risks and challenges before external or regulatory audits.

Rahway, New Jersey, Us

• Created and implemented KPIs, SLAs, Quality Gates, and a Training Program for the IT Managed Services Framework. This global framework sets service quality standards and ensures inspection readiness for the company’s service providers. The program has also led to 10% year over year cost savings.

Rahway, New Jersey, Us

• Led a global team who provided IT quality / technical writing services for Systems Development Life Cycle documentation. This resulted in concise written documents which helped increase productivity, consistency, and credibility to auditors and inspectors. • Developed and implemented the global systems quality assurance and software testing frameworks which boosted customer satisfaction and positive user experiences.• Provided IT quality support on the end-to-end testing of the Multi-Channel Management (MCM) and Model-N Align projects in the Human Health Division. This included establishing a Manual and Automated Testing Strategy which resulted in higher test coverage, reusability of test suites, and faster time to market.

Rahway, New Jersey, Us

• Developed the GAMP / GxP aligned infrastructure framework to optimize the overall qualification effort and improve the company’s compliance posture. This framework also resulted in safeguarding reliability, security, and business continuity for regulated company software and data.• Supported the Sarbanes-Oxley (SOx) Program for Infrastructure Operations to ensure compliance with certain practices in financial record keeping and reporting for the company.

Rahway, New Jersey, Us

- Managed and supported systems activities associated with RAS-Analytical laboratory systems, which includes validation documentation, system maintenance, systems changes, upgrades, anomaly resolutions, SOP management, training, and following system life cycle methodologies, procedures, guidelines, and policies.- Managed and provided direction to the laboratory systems support group to assure that such systems, computer applications, and interfaces, regulated by cGMPs, are documented and employed in a manner that is compliant with Federal regulations, company policies, and standard operating procedures. - Supported increased efficiencies and implementing streamlined / risk-based approaches to laboratory system qualification, maintenance, and calibration for Merck. This included supporting the HPLC User Group Team, Computer Validation Coordinator activity, the Laboratory Qualification & Validation Committee, and the Laboratory Asset Maintenance Program. In addition, this also included supporting and deploying divisional / corporate laboratory system solutions to RAS-Analytical Laboratories.- Assisted in capital and profit planning for all systems related projects / personnel for RAS.

Rahway, New Jersey, Us

- Provided regulatory guidance to Merck Manufacturing Division (MMD) worldwide on the implementation of System Life Cycle (automation and computer validation) methodologies. - Provided expertise and guidance to project teams for new systems and on the maintenance of existing operational systems. Systems included the Computer Maintenance Management System (MAXIMO), WorldWide Atypical Tracking System (WATS), various Laboratory Instruments, ClearQuest/Clear Case, and eNotebook. Acted as the GxP Quality Approver for the SDLC documentation associated such GxP systems.- Assisted in writing and obtaining approval for new and revisions to existing validations guidelines and/or guidance documents.- Provided System Life Cycle (automation and computer validation) methodology and guideline training. Conducted such SDLC training in-person world-wide to numerous Manufacturing engineers and software developers.- Assisted in the development of industry positions on GxP computer validation for input to industry/trade groups and/or regulatory agencies.- Led a cross-functional team in updating the System Classification Validation Guideline that impacts Information, Manufacturing Automation, and Laboratory Systems that are cGMP in nature.- Assisted in the implementation, tracking and execution of the 21 CFR Part 11 (Electronic Records/Electronic Signatures) program throughout Merck Manufacturing Division (MMD) world-wide.- Represented MMD Regulatory Quality on various Merck System Life Cycle Special Interest Groups and Teams

Rahway, New Jersey, Us

- Managed and supported all automation activities in the Varicella Manufacturing facility, which included computer validation documentation, system maintenance, automation changes, upgrades, anomaly resolutions, SOP management, training, and following system life cycle methodologies, procedures, guidelines, and policies. Technology included Staubli Robots, Allen-Bradley PLCs, RSView, Intellution Fix32, Millipore Filter Integrity Testers, and the Wheaton Roller Cart Monitoring System. Participated in extensive Y2K (Year 2000) activities, which included upgrading the Wheaton Roller Cart Monitoring System and SCADA applications for the Temperature and Data Acquisition System associated with the Staubli Robots and the Varicella Thermal Inactivation Skid.- Deployed the Worldwide Atypical Tracking System to Vaccine Operations, which is an electronic signature system for atypical events that occur either during manufacturing or quality control laboratory testing.- Managed 3 automation engineers on the Standard Data Order Writing Replacement project (DocCompliance®) which included UAT, scheduling of testing, test incident reporting, SOP development, system configuration, data migration, and on-going communication with software developers. Maintained communication with business project leader, Automation & Information Technology group, and Quality Assurance representatives. - Supported various Computer Validation Coordinator and 21 CFR Part 11 activities for Vaccine Operations. This included providing guidance on computer validation documentation, spreadsheet validation, and 21 CFR Part 11 assessments and remediation.- Managed 6 automation engineers supporting WATS, POMS, BTMC RF System, PLCs, BTMC BAS, and the Standard Data Order Writing Replacement project.

Rahway, New Jersey, Us

- Deployed the Electronic Release & Protocol Preparation System (ER&PPS), which allowed release protocols to be submitted to CBER electronically and to be maintained in the Saros Document Manager. Coordinated deployment with CBER and Biological Product Release personnel.- Supervised release clerks in using the ER&PPS and other office software/hardware.- Provided various automation support to department which included Y2K (Year 2000) activities, spreadsheet validation, PE LIMS project, Decision Support System project, and various software upgrades.

Rahway, New Jersey, Us

- Managed the Beckman Laboratory Information Management System (LIMS), which included computer validation documentation, system maintenance, automation changes, upgrades, anomaly resolutions, training, and following system life cycle methodologies, procedures, guidelines, and policies. Upgraded the VAX/VMS Operating System on LIMS, which included various functional testing.- Managed other automated laboratory systems, which included HPLC networks, GCs, Near Infrared Systems, and Auto Analyzers (PDP/11+). Installed and tested Waters Expert Ease software for new HPLCs in the Ivomec Bolus Laboratory and upgraded existing HPLC software for the main laboratory.

Rahway, New Jersey, Us

- Managed the West Point Monitoring System and the Fire Protection System, which included over 5,000 various utility and fire prevention related alarms.- Tested and deployed the new West Point Monitoring System which included converting the system from MS DOS to UNIX. Worked closely with the selected System’s Integrator.- Maintained various databases and provided other system administrative functions for the department.

Rahway, New Jersey, Us

- Inspected and audited West Point’s GMP Pharmaceutical Packaging Operations and various other third-party packaging facilities.- Supported department on various office software and hardware.

B.S.E.E., Electrical Engeering (Computer Engineering Option)

High School