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
