Head of Engineering

4 weeks ago

Decatur, United States Rising Pharma Holdings, Inc. Full time

Responsible for the overall direction to the engineering function through the development of engineering policies and procedures consistent with organizational requirements and corporate standards, including:

Planning and Directing all areas of Facilities, Engineering and Maintenance / Calibration, Environmental Health and Safety and Validation functions. Planning and executing capital budgets and projects. Leading technical teams in meeting the needs of the plant operations.

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. • 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. The job holder supervises the following supervisors, engineers, and technicians and facilitates their efforts as a group in conjunction with the organization’s requirements: maintenance and calibration, project engineering, process engineering, environmental health and safety, and validation. All areas of formal supervision are included, such as performance appraisals, hiring, termination, work direction, and personnel development. Position Requirements: Education, Experience and Skills: Required:

BS in Mechanical, Electrical or Chemical Engineering 10+ years of engineering and maintenance experience in a pharmaceutical manufacturing operation with experience in sterile manufacturing. 10+ years of capital project management experience managing engineering resources and project managers in support of capital project execution. Process design, equipment selection, cost estimating, scheduling, and people management experience. Academic training or practical experience in financial analysis and economic evaluation is desired to ensure that proper business considerations are included in the decision-making process. Excellent communication skills in oral, written, and presentation situations provide clear, informative, and persuasive communication in positive and negative scenarios. Good analytical and computer skills are required. Must be able to prioritize critical versus non-critical issues and communicate to management and team leaders in clear, concise and timely manner Ability to establish credibility and trust amongst all levels of the organization. Ability to work under tight timelines and be able to motivate direct reports to deliver expected results. Working knowledge of MS Word, Excel, Outlook, and Power Point

Functional Knowledge:

Excellent conceptualizing, analytical and problem-solving skills Company- / industry-related knowledge:

cGMP, DEA, and OSHA compliance • Effective written and oral communication skills

• Strong organizational, planning, and communication skills. • Demonstrates exceptional time management skills. • Using logic and reasoning to identify solutions to problems. • Ability to multi-task, set priorities, and meet strict deadlines. • Ability to lead, motivate, coach, and teach others Rising Pharmaceuticals Bolsters U.S. Supply Chain by Expanding Sterile Dosage Capabilities, Including Injectables and Ophthalmics, with Opening of New Facility Rising Pharmaceuticals Bolsters U.S. Supply Chain by Expanding Sterile Dosage Capabilities, Including Injectables and Ophthalmics, with Opening of New Facility From our manufacturers, partners and pharmacies to physicians and their patients, our goal is to make life better for everyone we impact.

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