As a Warehouse Site Process Engineer • Process Development: Play a key role in the development and optimization of process/product flows, value stream mapping and introduction of automated systems (AGVs, Conveyors, Etc). • Documentation: Create standard operating procedures, maintenance strategies, PFMEA documents, change controls, and other documents critical to project delivery. • Regulatory Compliance: Ensure that automation systems meet corporate standards, including, but not limited to drawing management, version management, commissioning, qualification, validation, change management, and system maintenance. • Project Management: Manage all aspects of project delivery. Includes identifying user requirements, executing commissioning & qualification activities and scheduling to meet business and customer expectations. • Safety: Model safe behaviors within daily work. Provide support to the operational areas to address any safety concerns. Execute projects and activities according to HSE requirements. Draft and develop HSE workplans and participate in regulat • Data Integrity: Responsible for ensuring data integrity and good documentation practices while performing job tasks. • Knowledge Base Development • Excellent analytical, organizational, team, and project management skills • Strong documentation skills - should have experience in writing requirement specifications, design documents, installation protocols, test summary reports, etc. • Strong understanding of software development lifecycle and maintenance plans • Understanding of Pharmaceutical Warehouse Business Process
Roles & Responsibilities • Required work in person in a site along with the team of process engineers • Knowledge of cGMP, SAP, Trackwise (QMS) • Experience with Change Management, Deviation Management, Periodic Reviews, Commissioning & Qualification, Routine Data Monitoring / Reporting. • Ability to apply fundamental engineering principles to process understanding, problem solving and process improvement. • Experience with the principles of lean manufacturing to drive continuous improvement and operational excellence. • Ability to function in a team environment. • Effectively manage and prioritize competing priorities. • Strong verbal and written communications skills. This role must effectively communicate with Management, Operations, Maintenance, Quality, IT, and HSE. Must provide regular updates, conduct meetings, and produce presentations. • Strong self-management and organizational skills.
Generic Managerial Skills, • Manage all aspects of project delivery. Includes identifying user requirements, executing commissioning & qualification activities and scheduling to meet business and customer expectations.