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