David Kerr

I have worked in the Pharmaceutical, Biotech, and Medical Device industries since 2004. As a member of the Quality and Engineering Departments, I provide overall direction for the business unit validation function, ensuring product quality is maintained as well as striving for continuous improvements. My area of expertise is managing complex and multiple project objectives while developing, implementing, and monitoring of policies, procedures, methods, and processes.

Validation Lead (Independent Contractor) - Eli Lilly, IMA Automation, Johnson Controls, Keenova - Lebanon, IN; Elgin, IL; Indianapolis, IN; Baton Rouge, LA

(2024-09)

• Lead all utility commissioning activities for 5 buildings for a $3B project
• Supervise the SAT activities at the customer site for a four loop high speed custom automated machine
• Wrote risk assessments, Functional Design Specifications and procedures
• Lead Validation Engineer for all validation activities on site

Manager of Engineering and Validation - FujiFilm Diosynth Biotech - College Station, TX

(2023-03 - 2024-06)

• Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals
• Mentor and support validation activities for vial preparation and filling
• Supervise the activities of the corresponding manufacturing building's internal validation staff as well as external validation contractors. Establishes validation priorities to ensure that deadlines are met
• Pre-approve qualification protocols and post-approve summary reports
• Performs assessments of all change controls with an accurate understanding of the implications of changes
• Create, review, and update VPPs, SIAs, Risk Assessments, SOPs, forms, templates, documentation, and files
• Monitor the performance of the validation activities of the corresponding manufacturing building by tracking appropriate metrics and reporting the results to Senior Leadership Team

Senior Validation Manager – Independent Contractor - Fresenius Kabi, Baxter Healthcare, Abbott Laboratories, IMA Automation - Melrose Park, IL; Round Lake, IL; Abbott Park, IL; La Chaux de Fonds, Switzerland

(2020-06 - 2022-12)

• Directed the Validation Activities of the R&D Division for Abbott Diagnostic Division
• Authoring Installation and Operational Qualification protocols for critical utilities and facilities
• Managing all calibration registration for all devices for a $150M project
• SAT execution activities for North American customers during the Covid pandemic
• Commissioning of new processes
• Procedure writing and updating

Manager of Quality, Validation Engineering, and Metrology - Flex - Buffalo Grove, IL

(2018-02 - 2020-06)

• Created the Validation Department at the Buffalo Grove medical device site, including new commissioning, qualification and sustaining validation programs, processes, and procedures
• Led all validation activities for the site for all projects including a $500 million project
• Provide quality oversight of the equipment, facility and utility systems and computerized systems throughout the systems qualification lifecycle, and product and process lifecycle
• Responsible for ensuring effective site qualification and validation programs are developed, implemented and maintained in accordance with the organization's requirements, health authority requirements, and industry standards
• Directed 8 direct and 15 contract reports for over 60 high speed automated assembly machines, 6 packaging lines, SMT/PCBA machines, Building Automation System, cleanrooms, facilities, molding, utilities, and lab equipment
• Directed 9 direct reports (3 salaried and 6 hourly) for the metrology department, oversaw CT scan, OGP and CMM testing for all incoming projects and on-going manufacturing activities
• Oversaw closure of all CAPA and Non-conformances for the Validation, Metrology and Tooling departments
• Oversaw all external and internal quality audits for the Metrology and Validation departments; the Validation and Metrology department representative during customer and regulatory agencies site inspections

Manager of Engineering, Quality, Validation, and EHS - IMA - Rockford, IL

(2016-11 - 2018-02)

• Developed, established and maintained quality assurance programs, policies, processes, procedures and controls for injectable filling machines
• Led auditing activities for the company's ISO9001 certifications
• Directed all process engineering
• Directed change control, quality investigations and CAPA resolutions
• Responsible for defining and ensuring department goals and objectives are met
• Oversaw Validation Engineering, Quality and Process Engineering financial objectives by forecasting resource requirements; prepare an annual budget; schedule expenditures; analyze variances

Senior Engineering Project Manager - Innovative Pharma Consulting Partners - Woodstock, IL; Portage, IN

(2015-07 - 2016-11)

• Generated User Requirement Specification for critical equipment and directed the engineering testing for this equipment
• Developed process validation plans and protocols for new products
• Executed and closed cleaning validation projects for new products
• Created the Requalification program and operating procedures for a pharmaceutical film manufacturing facility

Senior Project Validation Engineer - ATS Sortimat - Rolling Meadows, IL

(2014-02 - 2015-07)

• Directed large engineering and validation projects for fully automated equipment ($10M+)
• Supervised 4 validation engineers and 1 senior technical writer
• Lead internal and customer design reviews injectable machines
• Defined and implemented acceptance criteria, specifications, and standards for each qualification activity
• Created Functional, Software, and Hardware Design Specifications; Risk Assessments; Traceability Matrices; Installation and Operational Verification protocols; and Commissioning and Qualification documentation as needed per customer requirements

Senior Quality Validation Engineer - Catalent Pharma Solutions - Woodstock, IL

(2011-06 - 2014-02)

Validation Project Lead of process validation for new products, including planning and coordination of step-up, engineering, and validation batches. These projects include FMEA activities, batch record development, engineering studies and process implementation testing while managing 3 validation personnel and up to 7 manufacturing personnel per shift during process validation. I developed and executed all engineering studies and process validation protocols

• Validation Project Manager for a new, plant-wide automated data collection system used to record critical in-process parameters for all batch records
• Qualified Blow/Fill/Seal filling machines for 3 projects
• Commissioned and qualified a building management system (BMS), automated packaging line, vision systems and facilities

Computer Validation Engineer - Fresenius Kabi - Melrose Park, IL

(2008-12 - 2011-06)

• Metrology Supervisor, overseeing 4 calibration technicians
• Project team member for a Green Belt project analyzing efficiency of product filling lines
• Created the Quality evaluation program of automated equipment for parenteral manufacturing facility
• Computer Validation Engineer in charge of Quality evaluations of all automated systems
• Qualified parenteral filling lines for new products

Validation Engineer - Commissioning Agents, Inc. - Indianapolis, IN

(2004-04 - 2008-12)

• Executed startup/functional testing for 18 bioreactors and system troubleshooting
• Validated a parenteral fill machine and line from writing URS to writing and execution qualification documents
• Executed startup/functional testing and system design walkdowns for new lab systems including Pharmaceutical Compressed Air, Water for Injection, Clean Steam and Water for Bulk Sterile Operations systems
• Project Manager of large-scale trend analysis for over 30 air handling units as part of air handling unit remediation, managing 3 other validation engineers on the