Alex M. Pavloff Jr.

*** ***** ****** **** **** Cell: 484-***-****

Covington, LA 70435 adlv4i@r.postjobfree.com

Senior IT Validation Consultant

Results-oriented, resourceful, and forward-thinking IT management professional with comprehensive experience in leadership of systems validation and implementation, in FDA regulated industries. Multi-faceted, hands-on and proactive project manager and consultant with demonstrated success in development of strategic business solutions that enhance software quality processes and productivity. Proven ability to adapt to new technologies and quickly learn new operating environments. Collaborative and versatile team leader and consultant with excellent communications and interpersonal abilities to build rapport with all levels of customers, management, other key stakeholders to resolve complex problems, while ensuring effective collaboration.

Areas of Expertise

Computerized System Validation Project Management IT Auditing Training (Development and Delivery) FDA Regulations (GxP and 21 CFR Part 11) Risk Analysis Data Integrity GAMP 5 Software Quality Gap Assessment User Requirements and Process Flow Analysis Clinical Systems Validation Cloud Based System Validation Agile Software Development Development of Validation Deliverables Root Cause Analysis (CAPA) System Implementation Analysis Quality Systems SOPs/Policies/Procedures Development Staff Supervision/Performance Management Quality Assurance Operating from a home office

Technical Proficiency

SAP, HP ALM with Vera, NuGenesis, Trackwise; Veeva, Automated Inspection Systems; Rockwell Automation; Document Management Systems; NuGenesis; Werum MES; Siemens and Honeywell BMS; Windchill PLM; Winrunner; PV Works; ClinPlus; Labware LIMS; Plateau; Sharepoint; JIRA; Mountain Goat Software, Microsoft Office Suite

Professional Experience

Biogen, Raleigh, NC April 2020 – April 2021

Experis

Validation Analyst - remote

CSV re-validation for systems that support R&D and Pharmacovigilance including NuGenesis, Labware LIMS, PML Case Management (AE Repository), Brazil PV (Pharmacovigilance).

Mylan Pharmaceuticals, Morgantown, WV Sep 2019 – Mar 2020

Pharmasys

CSV SME

CSV re-validation for manufacturing equipment and supporting systems at Mylan’s Morgantown, WV finished dosage manufacturing facility. Automated systems included: Fette Tablet Presses, Hata Tablet Presses, Fluid Bed Dryers, Checkweighers.

Takeda Pharmaceuticals, Deerfield, IL Dec 2018 – July 2019

Pharma Quality Europe

Validation Lead

Execute the SAP Systems Validation Strategy in accordance with the Master Validation Plan

Coordinate with the Local and Core Team to maintain/ensure compliance of the BPR SAP documentation and validation strategy.

Development of Validation Deliverables

Coordination of BPR SAP validation activities and deliverables against an agreed project plan.

Support and coordinate BPR SAP validation and training activities with project core and site members.

Manage multi-site validation team and maintain alignment.

Resource planning according to the agreed budget and milestones.

Validation of Veeva System upgrades and enhancements.

Alex M. Pavloff Jr. Page 2

AMRI, Rochester, NY Dec 2017

Pharma Quality Europe

Sr. CSV Consultant

Responsible for developing and executing the validation strategy for migrating 12 laboratory instruments from local data storage to secure network storage.

Responsible for developing CSV SOP training documentation in order to enable an easier transfer of knowledge.

Luitpold Pharmaceuticals, Shirley, NY May 2017 – Nov 2017

Oxford International

Sr. CSV Consultant

Responsible for validation of a dictionary upgrade for PV Works.

Managed the validation of the HMI for a new Bosch vial inspection system.

Executed the remediation necessary to close out five System Periodic Evaluation Reports

Virbac Animal Health – St. Louis, MO July 2016 – May 2017

Oxford International

CSV Consultant

Review and update of CSV SOPs for improved efficiency and compliance .

Responsible for managing a paper to Infor EAM Maintenance Management validation project.

Responsible for managing a KMC Building Management validation project for production stability chambers and a warehouse.

CBOS - Brighton, MI April 2016 – June 2016

Black Diamond Networks

Professional Services Consultant

Responsible for interfacing with CEBOS Life Science clients in discovery sessions to develop User Requirements and Functional Specifications and transfer them to the CEBOS Professional Services Engineer to develop the custom product solution for the client.

Responsible for system configuration, executing conference room pilot sessions and developing and executing OQ Scripts.

USDM Life Sciences, Santa Barbara, CA Apr 2015 – Dec 2015

Sr. Validation Consultant

Responsible for managing a Camstar and Epicor validation project for a site-wide implementation at a medical device company.

Responsible for managing a SAPBD validation project for a site-wide implementation.

Biomarin – Novato, CA Sep 2014 – March 2015

Pro Unlimited – Burlingame, CA

Automation Project Manager

Responsible for managing a plant automation project involving the iBatch upgrade of 6 chromatography skids.

Responsible for ensuring that software quality practices were adhered to.

Responsible for providing Sr. Management personnel with project performance information, alerts of any issues and project reports and a dashboard with key performance indicators.

Conduct weekly and ad hoc meetings with the project team and supporting personnel on the performance of the project, updates on issues and delayed tasks and management of project changes.

Alex M. Pavloff Jr. Page 3

Azzur Group LLC – Willow Grove, PA Apr 2013 – Sep 2014

Director

Consultant – Medical Device Company – West Chester, PA

Oversee and provide direction for GXP software revalidation projects including gap assessment, strategic planning and implementation ensuring compliance with all quality, SDLC policies and procedures, and regulations for a medical device company.

Key Achievement:

Validation SME and project leader to ensure proper validation strategy and implementation is compliant with all regulatory requirements.

Novartis Consumer Health – Lincoln, NE Nov 2011 – Mar 2013

Manager – QA/IT Support

Managed and provided direction for the validation of local lab, shop floor, MES, Building Automation Systems and IT computerized systems and applications with responsibility for ensuring compliance with the company and local health authority’s quality system requirements.

Key Achievements:

Validation Project Manager for oversight and management of all project deliverables including on-time delivery of projects with a thorough understanding of all QA and business unit functions to support and ensure CS applications fulfilled all customer QA and business unit needs.

Aligned department goals with global QA and business objectives to measure performance against objective standards; implemented system revision efforts in coordination with user communities.

Identified and collaborated with internal and external customers to establish service standards in accordance with Novartis’ Commitment to Quality and Customer Orientation.

Medidata Solutions – New York, NY Jun 2008 – Nov 2011

Director

Oversaw and managed development of effective and efficient Agile software development and testing procedures to ensure compliance with applicable clinical global regulations and guidelines.

Key Achievements:

Collaborated with Research and Development and Software Quality groups to assess all software products and SAAS services to ensure accuracy in development of Agile software and testing procedures.

Key Member of Software Upgrade Project Teams of Agile software product development and testing for Designer, Grants Manager and CRO Contractor to ensure quality compliance with final product release approval.

Wyeth Pharmaceuticals – Collegeville, PA Feb 2003 – Apr 2008

Senior Audit Manager II – Global Compliance Auditing / Information Systems

Managed the planning, execution and reporting of complex internal and external audits based on regulatory risk of enterprise and local information systems, automated manufacturing systems, computer rooms at remote sites, CROs, and software vendors to determine the level of compliance with applicable regulations, company SOPs and Wyeth Division Guidance and Conformance Standards.

Key Achievements:

Oversaw audits to continuously improve the GXP compliance status of regulated Wyeth Information Systems, Information Systems Department, and related corporate departments or affiliates that might affect research and marketed products.

Developed and authored audit reports containing expert high-level assessments and recommendations for remediation based on root cause analysis.

Alex M. Pavloff Jr. Page 4

Other Professional Experience

Genzyme Corporation - Framingham, MA

oGroup Leader Sep 1999 – Feb 2003

oPrinciple Validation Engineer Jun 1996 – Sep 1999

CRB Consulting Engineers, Inc. - Kansas City, MO

oComputer Validation Project Manager Jun 1995 – Jun 1996

Burroughs Wellcome Co. - Greenville, NC

oQA Validation Support Specialist Mar 1994 – Jun 1995

Clinarium, Inc. – Wayne, PA

oValidation Project Manager Oct 1992 – Mar 1994

McNeil Consumer Products – Fort Washington, PA

oSenior Programmer Analyst May 1990 – Oct 1992

R.W. Johnson Pharmaceutical Research Institute – Spring House, PA

oQA Senior Programmer Analyst Oct 1988 – May 1990

SmithKline Beckman Corporation – King of Prussia, PA

oRegulatory Quality Assurance Systems Analyst Jun 1986 – Oct 1988

Johnson Matthey, Inc. Catalytic Systems – Devon, PA

oProgrammer Analyst Jun 1984 – Jun 1986

Education

Ursinus College, Collegeville, PA – Bachelor of Business Administration: Computer Science, Dec 1991

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