Manager Production Engineering is responsible for set up, analysis and improvement of technical operations for all products. He/she provides technical support for the day to day operations of the facilities. In addition, this role is involved with all aspects of transferring new technology and products from the Product Development group into validated production processes (process design, scale-up, equipment support, infrastructure, etc.).
Essential Duties and Responsibilities: (other duties may be assigned)
• Manage a team of engineers to provide sound knowledge and understanding of process and/or product design principles to analyze, improve and optimize the engineering, procurement and production for existing or new products and processes.
• Lead efficiency and quality improvements in production areas and assist with the overall site quality and regulatory compliance efforts.
• Participate as a member of cross-functional project teams for Product Development projects to implement robust manufacturing processes, equipment, material handling systems, and maintenance strategies that function as designed.
• Manage the set-up of pilot lines and infrastructure to perform development runs on new products/processes.
• Provide technical input and support to internal customers on issues of manufacturing equipment, process changes, test methods, validation, regulatory compliance, failure investigation, risk analysis, and commissioning of new systems.
• Understand and employ scientific and engineering practices according to industry standards; apply expertise to solve typical as well as non-standard problems within API Manufacturing.
• Review process analytical data, deviation reports, batch records and other process documents as part of the batch evaluation and disposition process.
• Support Manufacturing Supervisors and team members with the focus on developing good work habits and training systems to build knowledge and proficiency in API Manufacturing.
• Recommend measures to improve production methods, equipment performance, and quality of product. Suggest changes in use of equipment to increase efficiency and/or improve safety of API and FDF Manufacturing.
• Provide coaching and mentoring to direct staff and support positions to enrich their professional development.
• Support and comply with all quality management systems, continuous improvement programs, employee safety, and preventative maintenance programs.
• Direct and enforce compliance with all governmental regulations including but not limited to FDA, DEA, EPA/WDEQ and OSHA.
• Work within budgetary/financial objectives set by the Vice President Operations.
• Perform other activities as assigned.
• Leadership - Strong leadership, mentoring, coaching and communication skills. Works well in a team environment, and is able to react quickly to changing business needs. Demonstrated ability to prioritize, manage and schedule in a high volume environment to meet project and department objectives while maintaining quality goals.
• Technical Knowledge – Strong practical knowledge in engineering, process design, documentation, and equipment design and operation for API and/or fine chemicals facilities; Knowledge of Quality by Design and pharmaceutical regulatory requirements specified in 21CFR 210 and 211, ICH Q7a, ICH Q11, and other applicable ICH guidance documents, preferred; Demonstrated ability to develop, modify and interpret Process Flow Diagrams (PFD’s) and Piping and Instrumentation Diagrams (P&ID’s).
• Communication - Must have excellent interpersonal skills; experience in communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers, contractors, and staff from various departments. Effective administration and technical writing skills, including ability to write and review protocols, data analysis, and other technical reports and documents.
• Adaptability - Adapts to changes in the work environment, manages competing demands and is able to deal with frequent change, delays or unexpected events. Must be highly self-motivated, well organized, and be able to develop alternative solutions to complex issues.
• Dependability - Highly self-motivated, well organized, and have strong analytical and problems solving ability to be able to develop alternative solutions to complex issues.
• Computer Skills - Strong familiarity with MS Office including MS Project applications, statistical analysis, and scheduling programs. Proficiency with use of AutoCAD, HYSYS, CHEMCAD, or similar programs preferred.
• Safety and security - actively promotes and personally observes safety and security procedures, and uses equipment and materials properly.
• Operational Excellence – Experience with implementing Lean Manufacturing techniques, or equivalent.
BS in Chemical Engineering or related engineering degree required; Master’s degree preferred.
6 years of experience in manufacturing or engineering functions for API or specialty chemical manufacturing required. Demonstrated knowledge of cGMPs and commercial manufacturing is preferred. Work experience with product testing methods is a plus.