The Maintenance Compliance Engineer functions as part of an integrated team to provide Maintenance and Engineering support to on-going Sterile Injectable operation areas of the Rochester, MI plant. This position works directly with the Maintenance Team Leader and is integrated with the team of craftsmen and enablers who support that same operating area of responsibility. General responsibilities are to provide the technical program leadership and implementation activities to maximize the maintenance-related uptime and operating efficiencies of equipment and facility assets. This role is also responsible for optimizing Preventative Maintenance (PM) strategies and for updating the associated planning and tracking systems. This position interacts extensively with the Operations Area in a business partner arrangement to achieve mutual production and uptime goals. The Maintenance Compliance Engineer also functions as an integral team member and Subject Matter Expert to support investigations, master planning & capital projects in the area of responsibility. The Rochester site is a penicillin manufacturing facility. Candidate must not be allergic to penicillin.
Works closely with the operations and Engineering teams to target maintainability issues, lower maintenance costs, and implement improvements.
Leads investigations, manages change controls and develops/implements Corrective and Preventative Actions (CAPA's) for the maintenance department
Establishes the initial Preventive Maintenance / Calibration activities for equipment / instruments that are in accordance with the guidelines and specifications for that particular equipment / instrument class.
Extends, deactivates, and/or updates PM and Calibration activities through utilization of the PM / Calibration Optimization and Rationalization Program processes.
Selects the initial Maintenance Strategy for new equipment and provides updates to keep the strategy current.
Implements equipment reliability plans by ensuring job plans and tasks are established (Preventative Maintenance (PM), Predictive Maintenance (PdM), Calibrations, etc.).
Updates equipment reliability plans based upon Root Cause Failure Analysis results to further reduce the number of failures and minimize the effects of failures that do occur.
Performs root cause failure analysis of equipment deficiencies, develops, changes, and/or initiates maintenance activities such as PM, Condition Based Monitoring (CBM), lubrication programs, calibration, training, and spare parts strategies to improve performance and equipment availability.
Based on investigation results, develops design modification projects to improve performance and initiates work orders or capital projects to complete.
Provides input and oversight to equipment engineering standards.
Provide maintenance engineering input to Capital Project Engineering through equipment selection review, PM / Calibration activity development, spare parts needs, and training requirements.
Develops and implements plant safety improvements in their area of responsibility
- Education: Engineering Degree (BS or MS), from an Accredited Institution
- Experience: 3 years minimum related Maintenance Engineering, Project Engineering, Plant Engineering with BS
- 1 year minimum related Maintenance Engineering, Project Engineering, Plant Engineering with MBA/MS
- Language Skills: Excellent written and verbal communication skills required
Certificates, Licenses or Registrations: Certified Maintenance and Reliability Professional (CMRP) (or equivalent) desired, but not required
Experience with pharmaceutical manufacturing equipment and/or utility systems desired, but not required
Frequent sitting, standing, walking required. Ability to perform mathematical calculation and perform complex data analysis required.
The work environment ranges from office, to plant, to Maintenance shop. Colleague is frequently exposed to airborne particles and must work near moving mechanical parts. The noise level in the work environment is usually loud. Use of hearing, eye, hand and foot protection is required. Personal Protective Equipment applicable to the task must be worn at all times and is a condition of employment
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional travel may be required (
Candidate must not be allergic to penicillin.
Other Job Details:
- Last Date to Apply for Job: 9/17/21