What are the responsibilities and job description for the Director of Operations position at KYDA Partners Ltd?
Director of Equipment Operations
Location: San Antonio, Texas
Position Overview
We're seeking a strategic leader to serve as the Director of Equipment Operations. This critical role oversees the validation, maintenance, and performance of cutting-edge manufacturing equipment, ensuring compliance with FDA, AATB, and ISO standards while driving operational excellence. The successful candidate will lead a skilled team responsible for maintaining equipment across near 24/7 operations in two facilities with 23 cleanrooms.
Key Responsibilities
- Direct and lead equipment validation processes for new and existing manufacturing systems, ensuring adherence to regulatory requirements (FDA 21 CFR 820/1271, AATB, ISO).
- Manage the preventive maintenance programme for critical equipment, including ultralow freezers, refrigerated storage, steam sterilizers, ISO 6 cleanrooms, and packaging sealers.
- Supervise a team handling routine maintenance and minor repairs, and build strong partnerships with external vendors for complex repairs and advanced servicing needs.
- Serve as the PharmaWatch monitoring system administrator, ensuring compliance with equipment monitoring protocols.
- Oversee documentation for equipment-related activities in alignment with cGMP/CGTP standards, and support audits as required.
- Identify and implement opportunities for process improvement and equipment upgrades to enhance manufacturing operations.
- Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Production, to align equipment performance with organisational goals.
Skills & Experience Required
- Bachelor's degree in Engineering, Operations Management, or a related technical field.
- 7–10 years of experience in regulated industries (e.g., tissue manufacturing, medical devices, or laboratories) with a focus on equipment validation and maintenance.
- Proven expertise in FDA-regulated environments, specifically HCT/P or medical device manufacturing and cleanroom operations.
- Strong knowledge of regulatory standards, including FDA, AATB, and ISO.
- Experience managing vendor relationships, negotiating contracts, and implementing preventive maintenance programmes.
- Demonstrated leadership and team management skills with a focus on performance improvement.
Candidate Profile
The ideal candidate has a deep understanding of equipment validation, maintenance, and calibrations in a regulated manufacturing setting, preferably within the medical device or tissue bank industry. Familiarity with critical equipment (e.g., packaging sealers, ISO 6 cleanrooms, steam sterilizers, incubators) and experience scaling operations in high-compliance environments will distinguish top candidates. Strong leadership, cross-functional collaboration, and a commitment to continuous improvement are essential qualities for success.
