AmerisourceBergen Corporation Operations Engineering Director in LAKE FOREST, Illinois
Title: Operations Engineering Director Location: United States-Illinois-Lake Forest Job Number: 00001KTE
PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide. POSITION SUMMARY:
Lead the Operations Engineering organization with a focus on continuous improvement, construction, and compliance. Provide direction to the Senior Operations Manager on clean room qualification, recertification, and calibration activities and processes. Provide leadership and direction to managers responsible for clean room design and construction, large facility improvement projects, and clean room compliance improvement projects. Lead managers responsible for engineering and organizational procedure development and adherence regarding change control, clean room design and function compliance, and calibration compliance. Equal amounts of time will be spent on the managerial, leadership, performance management, and organizational development responsibilities. This position supports all compounding center locations, and is based in the corporate headquarters location in Lake Forest, IL.
PRIMARY DUTIES AND RESPONSIBILITIES: Set tactical and strategic policy, leadership, and direction in engineering policy, organizational policy, and facility compliance. Strategy is developed with knowledge of service requirements, growth forecasts, corporate objectives, regulatory requirements, schedule, cost objectives, and quality requirements. Provide leadership and direction to Senior Operations Manager whose team is responsible for clean room qualification and recertification, clean room design compliance, clean room continuous improvement, calibration, preventative maintenance system administration, and controlled drawings processes. Provide leadership and direction on facilities construction and improvement projects emphasizing clean room design optimization and compliance. Assess current state of clean room compliance and provide leadership on compliance improvement projects. Ensure critical compounding systems redundancy. Continually evaluate opportunities for productivity improvements in engineering, operations process improvements, clean room design and compliance improvements, and operations process improvements. Ensure standardization of formal procedures and processes for Engineering and Operations functions and for calibration, and change control activities. Develop capital and expense budgets. Monitor and control on a continual basis the expenditures for each budget. Develop and submit documentation to the Executive Team regarding current status of projects, compliance to schedules, strategic planning, and budget oversight. Adjust organizational structure as needed and perform employee hiring, termination, promotions, training, and development.
Qualifications: EXPERIENCE AND EDUCATIONAL REQUIREMENTS: BSME, BS Chemical Engineering, BSEE, or other related technical degree required. M.S. in engineering field desired. Minimum of 10 years of experience in medical device and/or pharmaceutical manufacturing (including 3-5 years of management experience). Aseptic facilities design and construction experience preferred. Detailed knowledge of FDA requirements for aseptic processing and for compounded sterile preparations. Extensive understanding of FDA cGMP compliance, risk based methodologies, validation, ISPE guidelines (i.e. GAMP 5), ISO standards (14644), and PDA guidelines. Experience in engineering and compliance strategy, CAPEX planning, and process improvement strategy. Experience with engineering processes (project reporting, standard operating methods, and change control). Knowledge of continuous improvement techniques (Lean/Six Sigma, OEE, SMED) Innovative, decisive, results oriented leader with strong coaching, problem-solving, and project management skills. Demonstrated ability to manage and develop staff (or make changes) and work effectively with all levels of organization. Excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, statistically evaluate solutions, and draw valid conclusions. Must be proficient in Microsoft Word, Project, Excel, and Outlook. Job: Operations Jobs