Purpose

The Director of Equipment Operations is responsible for overseeing the validation, maintenance, and repair processes of critical manufacturing equipment at RegenTX Partners. This role ensures that all equipment used in the production of RegenTX products meets regulatory requirements, functions optimally, and undergoes timely maintenance and repairs. Additionally, the Director will manage a team responsible for handling minor repairs and routine maintenance tasks, while overseeing relationships with external vendors for complex repairs and service needs, ensuring smooth day-to-day operations and maintaining rigorous internal operational standards. This role is crucial to ensuring the uninterrupted operation of manufacturing processes and supporting long-term production goals.

Responsibilities

• Lead the validation processes for all new manufacturing equipment to include guiding manufacturing operations on equipment selection and ensuring compliance with FDA and regulatory standards, including AATB, FDA and ISO.
• Develop and manage a comprehensive preventive maintenance program for critical equipment, such as: ultralow freezers, refrigerated storage, ISO 6 cleanrooms, steam sterilizers, packaging sealers and various desiccation equipment.
• Oversee a team responsible for routine maintenance and minor repairs to ensure operational efficiency and minimize downtime.
• Oversee relationships with external vendors responsible for complex repairs and advanced maintenance, ensuring high service levels and cost-effectiveness.
• Ensure all equipment-related activities are documented in accordance with FDA, AATB, and ISO standards, and support audits as needed.
• Work closely with the Quality Assurance, Regulatory Affairs, and Production teams to ensure all equipment meets the operational needs and quality standards of the organization.
• Serve as the primary administrator of the PharmaWatch equipment monitoring system, ensuring real-time tracking, reporting, and compliance with monitoring requirements for all critical equipment.
• Identify opportunities for process improvements and equipment upgrades, driving long-term operational excellence within the manufacturing environment.
• Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.
• Review and approve reimbursement requests for operational staff.
• Manage direct reports.
• Provide constructive feedback and guidance to develop leadership in direct reports and department management.
• Establish and monitor objective annual goals for direct reports.
• Conduct performance reviews and establish performance improvement plans as needed.
• Recruit, interview, and select personnel for hire.
• File and maintain records in accordance with standard operating procedures.
• Manage direct reports.
• Establish and monitor objective annual goals for direct reports.
• Conduct performance reviews and establish performance improvement plans as needed.
• Recruit, interview, and select personnel for hire.
• Travel domestically and internationally up to 5% to attend offsite meetings, conferences, and support business initiatives.
• Work overtime during weekdays and on the weekend as needed to support business/operational needs.
• Perform other related duties as assigned.

Skills

• Strong knowledge of regulatory standards, including FDA, AATB, and ISO requirements.
• Experience in developing and executing validations in an FDA-regulated industry is required.
• Proven experience in managing vendor relationships and negotiating service contracts.
• Excellent project management, organizational, and leadership skills.
• Strong communication skills with the ability to collaborate across teams and departments.
• Excellent attention to detail and organizational skills
• Strong Leadership skills.
• Ability to secure and maintain a favorable background investigation and clearance.

Qualifications/Requirements

• Bachelor’s Degree in a technical area such as Engineering, Operations Management, or related field from an accredited college or university required.
• At least of 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 is required.
• Experience in developing and executing validations in an FDA-regulated industry is required.
• Experience in HCT/P or medical device manufacturing and cleanroom environments is required.
• Clearance of favorable background investigation required.