PURPOSE AND SCOPE OF POSITION:
The Maintenance Engineer is responsible for providing all work-instructions, documentation on the installations/equipment for performing maintenance, installation and troubleshooting of mechanical/electrical (focused on electrical) equipment used in manufacturing, utility plants and analytical labs. All work to be completed to assure minimal impact to production while complying with cGxPs at Leiden’s manufacturing plant and training facility.
QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):
Education:
- Minimum of BS in Engineering (Electrical, Mechatronic, or related fields).
Experience:
- A minimum of 10 years of experience in maintenance/technical services of pharmaceutical manufacturing equipment is preferred
- Knowledge of fit-out works estimation. (Cost, manhours)
- Experience in working in an environment governed by SOPs and cGxPs
- Adaptable to a fast paced, complex and ever changing business environment.
- Ability to collaborate and work in a team environment; lead small projects and development of maintenance strategies.
- Significant ability and aptitude analyzing data to detecting inconsistencies, determining relative importance and to solve complex technical situations based on data
- Ability to communicate, collaborate and interact effectively with people with a variety of levels and disciplines including internal and external customers, vendors, contractors and operations staff.
- Knowledge of Maximo or other Computerized Maintenance Management Systems (CMMS) required
- Able to read, interprets, and understands electrical/mechanical drawings.
- Ability to review SOPs and work instructions
- Flexible and responsible
- Familiar with methods like FMEA, Risk based maintenance, criticality assessments,
- Self-motivated, pro-active, and able to work with minimal supervision
- Demonstrated success working in a high-performing, business results-driven environment.
- Excellent written and verbal communication skills
ROLES AND RESPONSIBILITIES:
- Ensure Asset Criticality ranking is performed to all area assets and define its maintenance strategy based in the asset criticality.
- Ensure compliance with EOHSS guidelines, cGxP regulations, Company policies and other external agency regulations.
- Responsible for accurate and safe job plans. This includes review and approval of all changes to job plans due to change control, equipment modification, etc.
- Works closely with Planning and Scheduling to develop standards for major maintenance overhauls and outages
- Understands spare parts needed for routine maintenance and ensures spare parts are available for run to failure equipment.
- Assist with implementation of Predictive Maintenance, and introduction of new technology
- Provide support to all maintenance technicians to assist with troubleshooting, act as expert for technical questions within the department and inter-department.
- Ensure vendor completed work meets the necessary maintenance standards and is handed over appropriately.
- Contact equipment vendors (if applicable) to report problems. Coordinate and implement vendor recommendations when approved
- Ensure all critical systems/assets meet customer needs. Implement or propose alterations, modifications, or replacement of existing equipment to reduce maintenance costs, equipment downtime or improve reliability.
- Own and drive operational excellence, by improving reliability, utilization and cost benefit by using historical maintenance/operational data and creation of performance metrics.
- Lead Root Cause Analysis, Kaizen, Failure Mode and Effects Analysis (FMEA) exercises in conjunction with System Owners, Reliability Technicians and Manufacturing Operators.
Working Conditions:
Willing to provide on call support to a 24/7 manufacturing site, and work nights or weekends when needed to support emergent issue resolution or project implementation
