Aaron Cardinal Email & Phone Number

Cleveland, Oh, Us

Cleveland, Oh, Us

Cleveland, Oh, Us

• Responsible for the implementation of a cleaning validation program, including a site remediation plan• Managed and scheduled the validation activities associated with moving four manufacturing facilities into one new building • Coordinated and oversaw the qualification activities of a new $2M fill line and cleanroom complex• Validation representative for a two-week FDA audit/inspection in which no 483’s were issued• Performed validation impact assessments associated with the change management, CAPA and deviation processes as well as provided recommendations as a member of the Change Management and CAPA review boards • 2016 VWR Presidential Award recipient based on individual performance given to the top 2% of VWR employees annually.

Meadville, Pennsylvania, Us

• Manage a project deck of 12 projects worth $11.9 million in savings and completed the implementation of two projects worth $6.1 million• Research production part fallout causes, identify areas of opportunity based on data, determine if projects are cost effective, develop project timelines and present project ideas to management to secure resources • Oversee engineers, testing facilities and operators to ensure project goals are met, complete quality control requirements and verify production has appropriate personnel and equipment to support new processes• Present validation data to receive project implementation approval and develop control plans to ensure project benefits are maintained

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Consent Decree Remediation team lead for the Sterility of Components team within the Sterility Assurance Work Stream tasked with completing Set the Standard, Gap Analysis and Project Planning• Project lead focused on updating sterilization master plans, qualification documents and process SOPs to remediate deficiencies and inconsistencies • Cross-functional investigation specialist tasked with leading teams in response to qualification related deviations and out of tolerance test results• Facility decommissioning lead for End of Life Resources, Scheduling, Testing and Calibration

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Oversee the day-to-day operations for the creation of schedules and coordination of executing sterilization equipment qualification projects within a multi-product GMP pharmaceutical manufacturing facility. This includes maintaining requalification schedule adherence, ensuring work is executed “right first time” in order to reduce equipment down time and communicating project activities and results to management• Support regulatory inspections as a subject matter expert by speaking on equipment qualification studies, providing support to management in response to auditor questions and working on teams preparing for potential auditor follow up questions• Approve validation documentation including protocols, deviations and investigations, reports, SOPs and validation assessments to support change controls• Supervise five internal resources and up to eight external consultants to ensure validation projects are executed to meet timelines and all appropriate standards.

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Validation lead for cross-functional project teams during multiple facility upgrades and factory startup tasked with the development of validation plans, schedules and assignments. Assignments include the design, qualification, and implementation to new and existing sterilization systems• Coordinate and supervise contractors to complete qualifications across multiple facilities • Develop, review and approve protocols, reports, deviation investigations and change controls

Ingelheim Am Rhein, Rhineland-Palatinate, De

• Initiator and project lead for the equipment upgrade of twelve Kaye 2000 validators, along with the addition of multi-stranded thermocouple wire use, to improve right first time, reduce department waste and shorten project timelines • Designed new protocol and report templates to improve audit review and response times• Updated moist heat sterilization acceptance criteria requirements according to regulatory guidelines• Plan and execute installation, operation and performance qualifications of sterilization equipment

• Travel to client facility for technology transfer and scale up of a Steam-In-Place system• System Administrator of a laboratory information management software (LIMS) program• Participate in client audits by providing documentation and conversing with clients to answer questions regarding validation policies• Update and maintain a media fill matrix to organize filtration and filling rooms, vial sizes, units filled, fill duration, operator performance and interventions performed

• Part of a team that qualified a newly constructed 30,000 square foot commercial-scale GMP manufacturing facility• Responsible for troubleshooting equipment or process malfunctions and documenting deviations, system failure, investigations and corrective actions • Project co-manager for the installation and qualification of a LIMS software program used to track Calibration and Preventive Maintenance, Stability Samples and Environmental Monitoring • Designed development studies for both new processing equipment and updates on existing equipment

• Author, review and execute validation protocols and final reports in a GMP compliant manner• Investigated an underperforming lyophilizer and through troubleshooting, testing and manufacturer consultations was able to significantly increased the sublimation rate capabilities of the unit • Authored new system and equipment SOPs and trained end users

• Managed and performed aseptic manufacturing activities including cleaning, material preparation, environmental monitoring, filling and everyday operations in a clinical manufacturing area• Responsible for the operation and maintenance of Controlled Environment Processing Area equipment including filling machines, lyophilizers, autoclaves, depyrogenation ovens, filling suite and isolators • Designed qualifications, composed and reviewed validation protocols, executed qualification studies, analyzed data and prepared final reports • Planned, constructed and organized a new materials management area

• Led a team of technicians in performing development and clinical trial material campaigns• Part of a team responsible for streamlining the design of soft wall isolators for processes including material pass-through, formulation, filtration, filling and freeze dryer loading of clinical trial products.

• Part of a team that constructed and qualified a clinical manufacturing filling suite with responsibilities including equipment installation and validation, equipment operation SME and writing SOPs• Fabricated a tray loading system and upgraded filling machines to improve process efficiency

• Cultured six different cancer cell lines and conducted viability studies comparing different APIs• Prepared and performed multiple experiments, approximately 10 per week running simultaneously• Recorded, graphed and analyzed sets of data, between 50 and 500 pieces of data per experiment to present to project management

Bachelor’S Degree, Biology

High School, General Studies