|Essential Duties and Responsibilities:
|• Provide leadership, guidance, training, and personnel development from both an administrative and technical base.
|• Develop short-term and long-term departmental and facility planning objectives to align with site objectives.
|• Guide departmental operations and personnel in accordance with company philosophies by way of performance reviews, training, and development programs, setting and tracking goals and objectives, and promoting fiscal responsibility.
|• • Institute and apply best engineering practices to ensure effective preventive, predictive, and corrective maintenance while maintaining continued operations with minimal downtime and uninterrupted plant operations.
|• Ensure all designs, materials, equipment, and day-to-day operations comply with cGMP requirements and practices.
|• Lead and support equipment and facility modifications to meet the needs of the operations, ensuring the appropriate cGMP guidelines are followed.
|• Facilitate the implementation of cost reductions, new product launches, and ongoing process equipment maintenance.
|• Provide appropriate technical knowledge and training to support the engineering team in writing detailed equipment, facility, or utility URS and specifications as necessary.
|• Provide troubleshooting guidance for equipment failures, as necessary.
|• Approve SOPs, safe practices, test reports, change controls, etc., as required.
|• Determine and provide appropriate engineering solutions and the most applicable technology applications to ensure optimal energy use and compliance with regulations on sustainability and energy reduction.
|• Enhance the troubleshooting skills within the department for all areas of responsibility.
|• Provide technical support and resources to other departments within the organization.
|• Improve systems such as calibration and maintenance, automation, etc. to enhance and improve the execution of the workload.
|• Oversee technical, financial, and managerial tasks associated with site-assigned capital budgets and capital project execution from conception to design, construction, and validation, and provide reports and communications as required.
|• Represent and foster harmonious relationships within the department and other site departments and corporate functions.
|• Interface with external regulatory authorities, organizations such as the FDA, EPA, OSHA, and DEA, insurance investigators, building / fire commissioners, and others as required.
|• Participate in internal and external audits as required or requested.
|• Ensure an effective interface between engineering, security, and EH&S resources and for planning, developing, and managing emergency response and business continuity.
|• Ensure that external resources and contractors working on the site are properly managed and their services are properly coordinated.
|• Development and support of approved department and facility operating and equipment capital budget responsibilities.