Ken Caulk

• Served as senior technical authority for sterilization activities of new/modified product integration and transfer initiatives across 6 medical device business units
• Provided scientific expertise for Gamma, E-Beam, and EO sterilization validation, requalification, and ongoing process monitoring
• Applied critical thinking skills and problem solving tools for sterilization-related risk assessments, deviations, investigations, and CAPAs.
• Authored, reviewed, and approved sterilization validation protocols and technical reports.
• Interacted with customers, FDA, Notified Bodies and other regulatory agencies during inspections related to sterilization, residuals, microbiology and bacterial endotoxins
• Performed supplier audits of contract microbiology labs and sterilization facilities.
• Provided oversight of qualification and performance monitoring of a radiation sterilization program across 5 manufacturing sites
• Communicated project status to stakeholders through structured reporting using SharePoint, Teams, Gantt charts, and quad‑slide summaries
• Led the development and validation of a low‑concentration EO sterilization cycle at a new contract sterilization facility, ensuring compliance with emerging EPA requirements to safeguard business continuity and expand process capability

• Led a team of 10 direct reports, providing training, setting performance goals, and conducting quarterly and annual evaluations
• Directed the EO and Gamma sterilization program for five business units and seven manufacturing facilities across North America, providing strategic oversight and technical leadership
• Developed and standardized a procedure for evaluating and documenting the patient risk of allowing Alternate Batch Release for endotoxin testing of product families following AAMI ST72
• Represented the sterilization function on a cross‑functional team evaluating a make‑versus‑buy strategy for sterilization services, ultimately guiding the decision to divest in‑house EO capabilities in favor of more cost‑effective, lower‑risk contract sterilization partners

• Coordinated and executed EO and gamma sterilization validations and requalifications per the facility master validation plans
• Provided technical expertise in biocompatibility testing supporting new and legacy products
• Served as senior technical authority for sterility assurance and sterilization activities supporting global medical device product portfolios
• Mentored junior scientists in sterilization science, regulatory expectations, and risk management related to sterilization, biocompatibility, microbiology and endotoxin testing
• Authored technical protocols and reports for sterilization activities and microbiological testing

Directed two research associates, overseeing their work and development. Provided technical expertise to 17 facilities worldwide in microbiology, aseptic processing, moist heat sterilization, gamma sterilization, and EO sterilization. Led audits of contract sterilizers and laboratories, managing travel budgets effectively.

Collaborated with medical device manufacturing plants to support development and validation of EO processes and assist in transferring processes to new locations. Acted as owner and subject matter expert for EO (re)qualification and process specifications. Supported representation of SA for devices regulated by FDA, TUV, and other regional regulatory bodies, including the Japanese Ministry of Health.

Designed and executed validation protocols for EO sterilization and EO equivalency studies/rationales. Managed EO pilot vessel area and the Sterility Assurance Cycle Request Program with 1 direct report.

Supported the EO sterilization program for multiple manufacturing facilities. Reviewed departmental standard procedures for compliance to ISO standards and FDA regulations.

Supported aseptic fill processes for parenteral drugs including sterility testing for batch release. Performed cleanroom qualifications and supervised routine environmental monitoring.