Equipment Engineer - Katalyst Healthcares & Life Sciences
Morris Plains, NJ 07950
About the Job
Responsibilities:
- 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.
- 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.
- On-time project completion.
- Engineering KPIs.
- Change Control KPIs.
- Customer satisfaction.
- Avoidance of critical observations during internal/external inspections.
- BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- Experienced in a GMP regulated environment (pharmaceutical preferable).
- Minimum 5 years of asset lifecycle experience.
- Experience with manufacturing and laboratory equipment and change controls.
- Experience with Computerized Maintenance Management System (Blue Mountain Regulatory Asset Management preferable).
- Strong oral and written communication skills.
- Ability to work independently with minimal direction.
- Self-directed and able to manage competing priorities
- Strong computer skills.
- Ability to focus on a variety of issues and drive to results.
- Ability to interact with a variety of organizational levels and foster cross-functional and cross-cultural team.
- Knowledge with manufacturing quality (manufacturing, equipment, facilities, critical systems, automation, validation, etc.)
- Experience with Quality Assurance, CAPA, Change Control, Document Control, Training Systems.
Source : Katalyst Healthcares & Life Sciences
