Computerized Systems Validation & Project Leadership
Resume:
PAUL H. JOHNSON
Moorpark, CA ***** 805-***-**** (cell) *********@*****.***
BUSINESS ANALYST, VALIDATION ENGINEER and PROJECT MANAGER for COMPUTERIZED SYSTEMS
Business Analyst, Validation Engineer and Project Manager for computerized systems with twenty years of experience in the development, validation, implementation and administration of software applications and computerized systems including enterprise-wide business information systems, quality management systems, device master records and batch records, clinical trial management, adverse event management, automated manufacturing equipment (with PLC), control and monitoring systems (SCADA), manufacturing execution systems (MES), enterprise resource planning (ERP), analytical instruments, data management systems, IT infrastructure and web-based applications.
Performed business process analysis and constructed business process maps
Conducted meetings to define system requirements and data flows
Wrote/Reviewed/Approved validation documentation
Executed validation protocols
Conducted data migration validation
Conducted gap assessments for 21CFR Part 11 compliance
Performed validated state reviews
Performed data integrity assessments
Initiated, investigated, and closed CAPAs
Performed IT supplier qualification
Conducted QA review of CSV documentation
Performed change control for documents and computerized systems
Wrote procedures for use, administration and maintenance of computerized systems
Created and improved computerized system validation policies, procedures and templates
Project manager for validation and often the entire computerized system implementation Key strengths:
Thorough knowledge of the system development life cycle, computer technology and project management
Experienced implementing companywide systems and working with globally dispersed project teams
Familiar with GAMP-5, 21CFR 11, 21CFR 820, 21CFR 58, ISO 13485, ISO 14971, and 21CFR 210/211
Certified Project Management Professional (Project Management Institute)
Certified Software Quality Engineer (American Society for Quality)
Certified Manager of Quality and Organizational Excellence (American Society for Quality)
Excellent technical writing skills and ability with MS Office (Word, Excel, PowerPoint, Outlook and Visio)
Expertise with project management tools (MS Project, Jira, SmartSheet)
Skilled at business process analysis
Eight years work experience managing projects and project teams PAUL H. JOHNSON
Moorpark, CA 93021 805-***-**** (cell) *********@*****.*** Page 2 of 4
PROFESSIONAL EXPERIENCE
STERLING DEVELOPMENT LLC Moorpark, CA (12/2017 – current) Computerized System Validation Engineer and Project Manager for various clients, including: Takeda Thousand Oaks, CA 7/2025 to 8/2025
Validation of changes to DeltaV configuration settings for part number and batch ID
Used Kneat for validation document management and test execution huMannity Medtec Valencia, CA 9/2024 to 3/2025
Updated the GxP computerized system validation program and established a Master Validation Plan
Validated Sage 100 Enterprise Resource Planning System for GxP use
Created and validated Excel spreadsheets for GxP use
Revised IT procedure for backup and recovery to be consistent with current practices SaniSure Camarillo, CA 11/2023 to 3/2024
Validated Infor SyteLine ERP for GxP use
IT Supplier Qualification of Infor as supplier of SyteLine ERP software
Wrote procedures for administration and maintenance of SyteLine ERP
Data Integrity Assessment for batch records
Azurity Pharmaceuticals (Remote) 10/2022 to 1/2023
GxP computerized system validation (SphereWMS warehouse management software) SmileDirectClub (Remote) 7/2022 to 9/2022
Audits of GxP computerized system validations and procedures Arcutis (Remote) 10/2021 to 3/2022
Wrote the company GxP computerized system validation program, created validation procedures and forms
Computerized system validation for GxP use (SAS validation) Abbott (Remote) 10/2021 to 3/2022
Project Management for GxP computerized system validation quality management system harmonization Amgen (Remote) 3/2020 to 10/2020
Business analysis for GxP computerized systems (OSIsoft PI), Computerized system validation (laboratory) Clinical Innovations Salt Lake City, UT 9/2019 to 1/2020
Validation of enterprise resource planning software for GxP use (Infor Visual ERP) Stryker Medical Redmond, WA 3/2019 to 8/2019
Revised / rewrote / created GxP computerized system validation procedures
Updated the GxP Computerized System Inventory List
Reviewed and approved of GxP computerized system validation documents
Trained staff on computerized system methodology, philosophy and established procedures Medtronic Northridge, CA 3/2018 to 7/2018
Validation Review and Re-Validation of GxP custom automated test systems STAAR SURGICAL Monrovia, CA (11/2015 to 10/2017)
Computerized System Validation Engineer and Project Manager for GxP Systems
Validation and implementation of InfoFlo ERP for host environment upgrade including data migration
Validation and implementation of JCI Metasys for facility monitoring and alarming
Wrote standard operating procedures for the use and the administration of computerized systems
Validation of MasterControl including data migration from legacy system
Validated product labelling systems and Minitab statistical analysis software
Validated TrendManager with Honeywell Electronic Data Recorder for steam sterilization batch records and Minitab for process monitoring and process improvement PAUL H. JOHNSON
Moorpark, CA 93021 805-***-**** (cell) *********@*****.*** Page 3 of 4
PACIFIC BIOSCIENCES Menlo Park, CA (4/2015 to 10/2015) Computerized System Validation Engineer for GxP Systems
Validation Master Plan writing for computerized systems
Validation of Salesforce.com upgrade with SAP interface
Camstar MES implementation
Wrote/revised standard operating procedures for computerized system validation and Oracle Agile PLM
Project Manager for the validation of site-wide equipment monitoring system BAXTER HEALTHCARE Westlake Village, CA (5/2014 to 11/2014) Computerized System Validation Engineer for GxP Systems
Implementation and validation of Emerson DeltaV and OSIsoft PI Historian
Validation and change control of Accelrys Discoverant
Tibco Spotfire query validation (business analytics reports)
Used Trackwise, Documentum, SharePoint and HP Quality Center ADVANCED BIONICS Valencia, CA (4/2011 to 1/2014)
Quality Systems Specialist, GxP Computerized System Validation Managed the computer system validation program at Advanced Bionics, trained and mentored staff, developed and validated computer systems, initiated and closed CAPAs, audited software vendors.
Validation gap assessment and remediation of computerized quality systems related to the physical relocation of those computerized systems
Database analysis for the migration of product complaint tracking from NetRegulus to SAP
Revised the computer system validation program to be consistent with GAMP-5, revised procedures and templates
Validated Camstar MES, DataFlo ERP, Oracle Agile PLM and custom software
Created forms and processes for device history records
Validated automated test equipment
Validation Lead and Project Manager of BarTender Label Printing System upgrade for Receiving Inspection
Validation Lead and Project manager for Merge Evolve for clinical trial management (now IBM eClinical) ARROW INTERNATIONAL Czech Republic (through Judge Research) (6/2008 to 1/2009) Computerized System Validation Engineer, Medical Device Manufacturing
Validated GxP automated manufacturing equipment used to produce spring wire guides for catheters for FDA compliance (coiling, cutting, grinding, stamping, welding, ultrasonic cleaning, and bending machines)
Trained staff on computerized system methodology, philosophy and established procedures B.BRAUN MEDICAL Irvine, CA (12/2006 to 5/2008)
Quality Assurance Specialist, GxP Computerized System Validation Validated automated equipment and facilities, laboratory analytical instruments, IT infrastructure, custom software applications and Excel spreadsheets.
Computer system validation lead for the installation of eight PLC-controlled packing lines and associated HMIs that reduced labor costs and increased throughput
Validated analytical instrumentation, including chromatography systems with Waters Millennium/Empower LIMS
Project Manager for the migration of software applications and files from two servers running obsolete Novell software to two servers running Windows, which reduced the business risks arising from depending on obsolete technology for critical business applications
PAUL H. JOHNSON
Moorpark, CA 93021 805-***-**** (cell) *********@*****.*** Page 4 of 4
METROPOLITAN WATER DISTRICT OF SOUTHERN CALIFORNIA Los Angeles, CA (3/2006 to 12/2007) Software Quality Analyst Consultant
Project Manager for the development, validation and implementation of custom software to control and manage water distribution in Southern California:
Automated process control software written in C that controls the flow of water through the Irvine Regulating Structure, which improved system reliability and reduced costs by eliminating the need for continuous operator attention and intervention
Web-based application used to manage the purchase, accounting, and reporting of electric power used to pump water through the Colorado River Aqueduct, which reduced costs by automating labor-intensive manual business processes
AMGEN Thousand Oaks, CA (5/2002 to 11/2005)
Computerized System Validation Engineer for GxP Systems Supervised validation contractors, and provided QA review and approval of the validation deliverables, for the work listed below:
Managed a team of validation engineers to implement and validate laboratory analytical instrument systems for 21CFR Part 11 compliance, including HP/Agilent chromatography systems with Chemstation LIMS
Validation of automation control systems and the associated HMIs (PLC, DCS, SCADA), laboratory instruments, controlled-temperature chambers and data systems used in a biologics manufacturing environment
Conducted gap assessments for 21CFR 11 compliance of Process Control Department computerized systems
Led the validation of an Emerson DeltaV Process Control System in a biotech manufacturing facility designed for the production of a billion-dollar biologic drug, including integration with OSIsoft PI Data Historian
Led the validation of a GE Fanuc Cimplicity Manager software version control system, which reduced the engineering costs for maintaining software backups and installing software upgrades (Completed the validation in five months by proactively scheduling QA resources for quick document turnaround)
Project Manager for the 21 CFR Part 11 compliance project for the metrology department. Managed the upgrade and validation of all metrology equipment, which brought the department into compliance with 21CFR Part 11. MERCK West Point, PA (through Kelly Services) (9/1999 to 4/2002) IT Consultant for GxP computerized systems – Various IT tasks as assigned
Managed an Oracle database of drug stability data (Used SQL scripts to load data and create reports)
Participated in the upgrade and revalidation of a Beckman Laboratory Information Management System (LIMS)
Created and validated Excel spreadsheets with VBA macros used to process and report laboratory data
Used Blue Mountain RAM software to manage equipment, equipment maintenance and equipment calibration PROFESSIONAL ACTIVITIES and ONLINE LINKS
Project Management Institute, American Chemical Society, American Society for Quality https://www.linkedin.com/in/paul-h-johnson-2414bb5/ https://www.sterlingdevelopment.biz/ CERTIFICATIONS
Project Management Institute, Certified Project Management Professional (PMP 1459468 since 31Aug2011) American Society for Quality, Certified Software Quality Engineer American Society for Quality, Certified Manager of Quality and Organizational Excellence ACADEMIC TRAINING
MS Chemistry, University of California, Berkeley
Business Supervision and Management Certificate, Ohlone College in Fremont, CA Client/Server and Database Technology Certificate, Pennsylvania State University
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