Stephen Jackowell Email & Phone Number

Fort Dodge, IA, US

Greenfield, IN, US

Greenfield, IN, US

Oversee all Quality and QC functions at the Fort Dodge facility and facilitate alignment remediation efforts for Est 196 (Fort Dodge, Winslow, Elwood).Fourteen years of experience supporting site regulatory inspections and audits (EU, VMD, FDA, USDA).Currently leading 79 Quality representatives in a site of ~400 people

Managed all Quality functions at the Winslow poultry vaccine manufacturing facility, working part time remotely in Fort Dodge and part time in Winslow. Approximately 120 site employees.

• Manage a team of up to 10 Validation Specialists to support Biological and Pharmaceutical Manufacturing Operations at two separate sites.
• Responsible for implementing current trends in regulatory compliance for all validation procedures, equipment, systems, and processes. Provide review and approval of validation protocols, reports and associated.
• Author critical investigation reports associated with validation deviations.
• Validation Project Manager for BSL-3 manufacturing facility and EU ready Biological Filling and Freeze Drying expansion project.
• Validation Subject Matter Expert during Change Control Committee meetings and provide approval of equipment and facility related change plans.
• Site SME for cleaning validation and steam sterilization applications.

Ingelheim Am Rhein, Rhineland-Palatinate, DE

• Manage a team of up to 10 Validation Specialists to support Biological and Pharmaceutical Manufacturing Operations at two separate sites.
• Responsible for implementing current trends in regulatory compliance for all validation procedures, equipment, systems, and processes. Provide review and approval of validation protocols, reports and associated.
• Author critical investigation reports associated with validation deviations.
• Validation Project Manager for new BSL-3 manufacturing facility and EU ready Biological Filling and Freeze Drying Capacity expansion project.
• Represent Technical Services as Validation Subject Matter Expert (SME) during Change Control Committee meetings and provide approval of equipment and facility related change plans.
• Site SME for cleaning validation and steam sterilization applications.

Building 32, Suite 400, Overland Park, Kansas, US

• Managed, tracked, and reported progress of validation projects by communicating through multiple departments
• Led the Change Control Committee from a Validation standpoint by providing input and approval of change controls issued to support the Biological and Small Volume Parenteral (SVP) areas
• Represented Technical Services in Biological and SVP meetings on a regular basis to provide validation support and help coordinate projects and validation activities
• Coordinated multiple projects to support product transfer projects and cleaning validation
• Managed 8 Calibration Specialists and 6 Validation Specialists

Building 32, Suite 400, Overland Park, Kansas, US

• Dedicated Validation Technician in the FDAH Small Volume Parenteral Area and Riverside Facility
• Designed testing strategies and methodology for the qualification and validation of products, cleaning processes, equipment, load patterns, utilities, and site facilities under direction of department supervisors
• Prepared, scheduled and executed validation protocols
• Performed Validation, Verification, and Validation Maintenance executions
• Prepared Protocol Summary Reports (PSR) following completion of Validation
• Volunteered to work 2nd or 3rd shifts and weekends to meet aggressive timelines

Building 32, Suite 400, Overland Park, Kansas, US

• Prepared Cleaning Validation Execution Packets that include documentation for successful protocol execution in the SVP facility and all manufacturing areas at Riverside
• Authored Protocol Summary Reports (PSR) following completion of Validation
• Assisted with all aspects of FDAH’s cleaning validations

Bachelor Of Science (Bs), Business Management

Associate Of Arts (A.A.), Business/Commerce, General

Education record