Director of Operations (Equipment)

KYDA Partners is seeking a Director of Equipment Operations critical to our partners mission, overseeing the validation, maintenance, and repair of specialized manufacturing equipment essential to near 24/7 production. This role is ideal for someone with extensive experience in equipment validations, maintenance, and calibrations—ideally within the medical device or tissue bank manufacturing sectors. You will lead a team of skilled technicians to ensure all equipment across two facilities, including 23 cleanrooms with plans of doubling by 2026, is fully compliant, reliable, and maintained to meet rigorous regulatory and operational standards.

Key Responsibilities:

• Lead Equipment Validation: Drive the validation of new equipment, particularly packaging sealers, tray sealers, incubators, steam sterilizers, desiccators, and cleanrooms (ISO 6). You’ll guide operational teams on selecting equipment that meets FDA and regulatory standards, prioritizing reliability and compliance.
• Preventive Maintenance Program: Develop and execute a comprehensive preventive maintenance program for critical equipment, including refrigerated storage, incubators, thermometers, and various R&D laboratory tools, 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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