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Director of Equipment Operations

1 month ago

San Antonio, Texas, United States Extremity Care Full time
Job Title: Director of Equipment Operations

At Extremity Care, we are seeking a highly skilled and experienced Director of Equipment Operations to join our team. This role is responsible for overseeing the validation, maintenance, and repair processes of critical manufacturing equipment, ensuring that all equipment meets regulatory requirements and functions optimally.

Key Responsibilities:
  • Equipment Validation: Lead the validation processes for all new manufacturing equipment, ensuring compliance with FDA and regulatory standards.
  • Preventive Maintenance: Develop and manage a comprehensive preventive maintenance program for critical equipment, including ultralow freezers, refrigerated storage, ISO 6 cleanrooms, steam sterilizers, packaging sealers, and desiccation equipment.
  • Team Management: Oversee a team responsible for routine maintenance and minor repairs, ensuring operational efficiency and minimizing downtime.
  • Vendor Relationships: Oversee relationships with external vendors responsible for complex repairs and advanced maintenance, ensuring high service levels and cost-effectiveness.
  • Documentation and Compliance: Ensure all equipment-related activities are documented in accordance with FDA, AATB, and ISO standards, and support audits as needed.
  • Collaboration: Work closely with the Quality Assurance, Regulatory Affairs, and Production teams to ensure all equipment meets operational needs and quality standards.
Requirements:
  • Education: Bachelor's Degree in a technical area such as Engineering, Operations Management, or related field from an accredited college or university.
  • Experience: At least 7-10 years of experience in a highly regulated industry such as tissue manufacturing, medical device, laboratory, or similar regulated manufacturing operations, with a focus on equipment validation and maintenance.
  • Skills: Strong knowledge of regulatory standards, including FDA, AATB, and ISO requirements, experience in developing and executing validations in an FDA-regulated industry, and proven experience in managing vendor relationships and negotiating service contracts.