Computerize Maintenance Management System / Utilities Sr Engineer

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Senior Utilities Engineer functions as the subject matter expert for maintenance software applications and utilities life cycle management.

CMMS Engineer: Ensures compliance of software applications for data integrity of the software and the use of the software by maintenance and other customers across the site. Ensures system upgrades, security patches and continuous automation of maintenance functions.

Utilities Engineer: Coordinates maintenance and projects associated with site wide Utility systems. Oversees Life Cycle management of utility systems for obsolescence and reliability.

Job Description

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

CMMS Activities

• Ensure data integrity of software systems and maintenance processes
• Manage asset life cycle process compliance
• Change Management for CMMS system and process revisions
• Support inspections and audits
• Manage continuous improvement and streamline maintenance processes with automation
• Oversee and maintain the CMMS training program.
• Manage user access control.
• Manage CMMS reports/metrics for continuous improvement and compliance adherence.
• Work Order system administration.  Triage work order submission to appropriate queues for execution.  Define/manage failure codes. Manage consistency within the system for reporting/metrics.  Escalate and communicate work order status and impact to production schedules.
• Ensure equipment/instrument enrollments and master data updates occur within project timelines.

40%

Utilities Activities

• Utility Systems include: City Water, RODI Water, WFI, Clean Steam, Compressed Air, Nitrogen, Fire Protection, Chilled Water, HVAC
• Manage lifecycle and maintenance of utilities systems by contractors and/or maintenance personnel
• Manage utility system upgrades
• Coordinate utility system shutdown activities
• Develop contractual strategy and framework to manage vendors / contractors and corresponding contracts in assigned site

30%

Project Management

• Responsible for the project management process including schedule, assignment, follow up, tracking, organization, and documentation.
• Financial project control (CAR Routing, Budget Tracking).

20%

Compliance Activities

• Manage utilities systems deviation, CAPA and continuous improvements
• Deviation and Investigation writing for maintenance events

10%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

• Associates Degree required, Bachelor’s Degree preferred.
• 5+ years working in the pharmaceutical, preferred.
• 7+ years in pharmaceutical or regulated industry experience such military, nuclear or aviation.
• 5+ years working in Maintenance is preferred

Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Familiar with FDA, cGMP regulations and guidelines
• Familiar with maintenance and related software systems.
• Familiar with parts inventory management.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Working in a sitting position at a compu