Operations Director

4 weeks ago


San Antonio, Texas, United States KYDA Partners Ltd Full time

KYDA Partners Ltd is seeking a seasoned professional to lead the validation, maintenance, and repair of specialized manufacturing equipment in a near 24/7 production environment. This critical role requires extensive experience in equipment validations, maintenance, and calibrations, preferably in regulated industries like tissue manufacturing, medical devices, or labs.

Key Responsibilities:

  • Lead Equipment Validation: Drive the validation of new equipment, prioritizing reliability and compliance with FDA and regulatory standards.
  • Preventive Maintenance Program: Develop and execute a comprehensive preventive maintenance program for critical equipment, ensuring optimal performance to support high-volume production.
  • Team Leadership: Manage and mentor a team responsible for routine maintenance and minor repairs, ensuring smooth day-to-day operations and minimizing downtime.
  • Vendor Management: Oversee relationships with external vendors for complex repairs, balancing service quality with cost-effective solutions.
  • Documentation & Compliance: Ensure all activities are thoroughly documented to meet FDA, AATB, and ISO standards and support audit readiness.
  • Cross-Department Collaboration: Collaborate closely with Quality Assurance, Regulatory Affairs, and Production teams to ensure equipment aligns with operational goals and quality benchmarks.
  • System Administration: Administer the PharmaWatch equipment monitoring system, enabling real-time tracking and compliance for critical equipment.
  • Continuous Improvement: Proactively identify areas for process improvements, upgrades, and new equipment to drive operational excellence in our expanding facilities.
  • Regulatory Knowledge: Maintain a deep understanding of FDA 21 CFR 1271, 21 CFR 820, AATB standards, ISO requirements, and internal SOPs.

Qualifications:

  • Education: Bachelor's Degree in Engineering, Operations Management, or a related technical field.
  • Experience: 7-10 years in regulated industries like tissue manufacturing, medical devices, or labs, with extensive experience in equipment validation and maintenance.
  • Industry-Specific Expertise: Background in medical device or tissue bank environments, specifically with cleanrooms and equipment like packaging sealers, tray sealers, steam sterilizers, desiccators, incubators, and thermometers, is highly preferred.

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