Job Purpose: Responsible for the management of the Asset Lifecycle Program for all equipment, systems, facilities and utilities at the Morris Plains site from procurement through decommissioning. Major Accountabilities: o Manage the Asset Lifecycle Program for all equipment, systems, facilities and utilities from procurement through decommissioning, including the following main functions: • Serve as the primary subject matter expert for the Asset Lifecyle Program. • Utilize Computerized Maintenance Management System (CMMS) to manage the following aspects of the Asset Lifecycle program: Enrollment/Installation Initial Entry into Service Removal & Return to Service Changes/modifications to assets, including relocation, repairs and parts replacement Scheduled events (e.g. calibration, preventative maintenance) and related Work Plan Templates, Measurement Data Templates and Sensor Risk Assessments Work requests/work orders, including processing, generation, tracking and follow-up; ensure work order completion, review, approval and close-out. Decommissioning • Manage Master Data for equipment object management in Manufacturing Execution System (MES) • Manage Standard Operating Procedures (SOPs), Work Procedures (WPs) and Forms related to Asset Lifecycle (e.g., equipment operation, calibration and preventative maintenance) including revisions and periodic reviews. Key Performance Indicators: o On-time project completion o Engineering KPIs o Change Control KPIs o Customer satisfaction o Avoidance of critical observations during internal/external inspections Ideal Background: Education: o BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree. Languages: Fluent in speaking / writing in English Experience: o Experienced in a GMP regulated environment (pharmaceutical preferable). o Minimum 5 years of asset lifecycle experience. o Experience with manufacturing and laboratory equipment and change controls. o Experience with Computerized Maintenance Management System (Blue Mountain Regulatory Asset Management preferable) Other Qualifications: o Strong oral and written communication skills o Ability to work independently with minimal direction o Self-directed and able to manage competing priorities o Strong computer skills o Ability to focus on a variety of issues and drive to results o Ability to interact with a variety of organizational levels and foster cross-functional and cross-cultural team o Knowledge with manufacturing quality (manufacturing, equipment, facilities, critical systems, automation, validation, etc.) o Experience with Quality Assurance, CAPA, Change Control, Document Control, Training Systems
