Facility & Reliability Engineer (21-05022)
Company: Axelon Services Corporation
Posted on: April 10, 2021
Job Description: The main purpose of the Facility and
Reliability Engineer is to implement a continuous improvement
strategy to support the New Jersey GMP Facilities to maintain a
qualified and regulatory compliant Facility Operation status. Main
responsibility will be the execution of the reliability program and
oversite of quality systems for facility related items for all GMP
and Non-GMP utility equipment and instrumentation. The Lead
Facility & Reliability Engineer will lead small-scale capital and
expense projects (20K to 250K) and coordinate large-scale capital
projects with Global Engineering to support the GMP facility
operations within New Jersey. The incumbent in this role will have
specific job tasks and processes to follow to perform their job.
The Lead Facility & Reliability Engineer supports the successful
operation of facility, laboratory and business functions at
multi-use GMP sites within New Jersey through interaction with
internal customers and external service providers. The role is
expected to be able to identify issues or unmet needs and initiates
projects or programs to address them. This individual works
collaboratively to complete assignments and oversees the successful
completion of tasks. Using solid analytical skills, the incumbent
can recognize problems of moderate scope and complexity, and
independently, develop potential solutions and courses of action.
This individual represents the work group on multi-disciplinary and
cross-functional teams and uses established relationships to
influence and lead teams and stakeholders with fact-based, business
REQUIRED COMPETENCIES: Knowledge, Skills, and 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
--- Strong knowledge of facility management systems such as CMMS
(Computerized Maintenance Management Systems).
--- 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
--- Familiarity with FDA / cGXP environments and associated
--- Adept in Microsoft Office Suite - Word, PowerPoint, MS Project,
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, IBC/IFC building codes, OSHA,
NFP, FM, LPDS and UL
--- Technical Knowledge
--- SOP writing skills
--- Problem Solving / Troubleshooting
--- Team Player
--- Customer Focus
--- Action Oriented / Tenacity
Education and Experience: --- BS degree in mechanical, electrical
engineering or similar engineering field
--- Minimum 5-8 years of facilities maintenance/operations
experience at an industrial or commercial site or related
experience and/or equivalent combination of education and
--- 2-5 years of GMP facility experience preferred but not
DUTIES AND RESPONSIBILITIES:
Facility Asset Management
--- Provides technical expertise, troubleshooting and improved
equipment maintenance/reliability strategies to optimize safe,
compliant, and efficient operations of all facility and utility
equipment and instrumentation.
--- Prepares asset files including equipment data sheets, impact
assessments, P&ID & drawings, factory O&Ms, factory
maintenance recommendations, maintenance work plans and
--- Assist in the development and management of a facility document
management program to track facility drawings, and project turnover
--- Lead on facility workstream to support large-scale project
asset and maintenance plan management. Project will require the
ability to identify and manage contract support to execute
according to project schedule.
--- Manage logbook strategies for facility equipment owned and
maintained by GMP Facilities.
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
--- Generates SOPs and Work Practices within Client's Document
Management System and electronic work plan template and measurement
data templates to establish the Use, Maintenance and Calibration
plans for GMP equipment.
--- Works with vendors to define vendor requirements to support
maintenance or calibration plans and contracts.
--- Initiates deviations for maintenance work orders that are out
--- Manages any CAPAs associated with the CMMS, including PMs or
Calibrations performed late or out of conformance
--- Execute criticality assessments for equipment and
--- Execute FMEA, RCA and identify alterative options to reduce or
--- Execute Historical trends to evaluate the criticality
assessment, FEMA and RCA for periodic review.
--- Reviews completed demand work orders for compliance with change
control and like-for-like procedures
--- Conducts Historical Performance Reviews on GMP Direct Impact
assets and Critical instrumentation maintained and calibrated by
the GMP Facilities Department
--- Initiates deviations for demand maintenance work orders or
preventative maintenance activities that are out of compliance
--- Support and track deviations, investigations and CAPA plans for
the GMP Facilities Department. Role will include conducting
detailed investigations to determine root cause and necessary CAPAs
by working cross functionally with Facility Management, QA,
Validation and Business Area Management.
--- Implement predictive maintenance tools to identify equipment
trending to failure to implement repairs prior to failure.
--- Support facility operations by providing operational SOPs to
manage GMP facility and equipment operations. Procedures may
include a USP Water System Operational Procedure or Facility
--- Promotes and maintains compliance with corporate, safety,
security and regulatory policies.
--- Maintains all assigned Corporate, Facilities, GMP and EHS
training as required
--- Oversee the LOTO and Confined Space procedures for GMP Facility
owned and maintained equipment.
Additional Job Requirements:
Job Requirements: FACILITIES,RELIABILITY,GOOD
Keywords: Axelon Services Corporation, Elizabeth , Facility & Reliability Engineer (21-05022), Engineering , Warren, New Jersey
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