Job Description
: Facility, Utility, and Equipment Reliability Specialist
Onsite Role, Warren site
Work Schedule: Mon - Fri, Business Hours
*Flexibility is required though as needs of the business warrant*
Position Overview:
The main purpose of the Facility, Utility, and Equipment Reliability Specialist is to evaluate facility and utility equipment and prepare effective/compliant maintenance plans and operating procedures. The incumbent in this role will have specific job tasks and processes to follow. The role is expected to evaluate the maintenance requirements for facility and utility equipment, and define the necessary work plans, routine parts and, critical spare parts required to provide reliable equipment lifecycle functionality. This individual works collaboratively to complete assignments and oversees the successful completion of tasks. The role requires experience with Computerized Maintenance Management Systems to follow administrative tasks to create and initiate maintenance plans.
Essential Functions:
Facility Asset Management - Provides technical expertise and improved equipment maintenance strategies to optimize safe, compliant, and
- efficient operations of all facility and utility equipment.
- Prepares asset files, P&ID & drawings, factory O&Ms, factory maintenance recommendations, maintenance work plans, and procedures.
- Support on facility workstream to support large-scale project asset and maintenance plan management.
Preventative Maintenance Work Plans - Establishes effective preventative and predictive maintenance plans for GMP Pharmaceutical facility & process
- utility equipment according to OEM recommendations, industry standards, and process application.
- Generates SOPs and Work Practices within Document Management Systems to establish the Use, Maintenance, and Calibration plans for equipment.
- Works with vendors to define vendor requirements to support maintenance or calibration plans.
- Review of maintenance work orders that are out of compliance or have non-conformance reports generated to evaluate the need for revised maintenance plans.
Continuous Improvement - Reviews completed utility and facility equipment demand work orders for compliance related to change control, like-for-like replacements, or reliability improvements.
- Reviews utility and facility equipment demand work orders for trends in failures or gaps in maintenance plans.
- Support facility operations by providing operational SOPs to manage GMP facility and equipment operations.
- Promotes and maintains compliance with corporate, safety, security and regulatory policies.
Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities: - Strong understanding of building systems including life-safety, lighting, mechanical, electrical, and plumbing.
- Strong knowledge of critical utility systems such as compressed gas, vacuum, waste, as well as security and key
- managements systems and policies
- Strong knowledge of facility CMMS (Computerized Maintenance Management Systems) applications such as
- BMRAM and Maximo.
- Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that
- may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
- Familiarity with FDA / cGXP environments and associated compliance regulations
- Adept in Microsoft Office Suite - Word, PowerPoint, Excel and Outlook, Visio and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.
- Proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Ability to follow oral and written instructions, read, interpret and update
- engineering manuals/drawings relevant to the trade or the assigned task
- Self-starter who is able to work both independently without direct supervision or in a team environment
- Knowledge of FDA regulations and local building codes
Competencies: - Technical Knowledge
- Problem Solving / Troubleshooting
- Team Player
- Multi-tasking
- Customer Focus
- Action Oriented / Tenacity
Education & Experience: - BS degree in mechanical, electrical engineering or similar engineering field
- Minimum 4-7 years of facilities maintenance/operations experience at an industrial or commercial site or related experience and/or equivalent combination of education and experience 4-7 years of GMP facility experience preferred but not required
Working Conditions:
Physical / Mental Demands: - Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 50lbs
- Ability to sit, stand, walk and move within workspace for extended periods
- Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling
- Ability to climb ladders and work in elevated areas.
Environmental Conditions: - Primarily office environment
- Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
- Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies
- Environment may include working at heights, in cold temperatures, and/or constricted spaces
- Ability to work safely when working alone, or working with others.
Additional Job Requirements:
None
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