Quality - Facility & Reliability Engineer

Job Summary

The purpose of the Facility and Reliability Engineer is to develop and implement a Reliability Centered Maintenance (RCM) strategy to support Summit West Cell Therapy Operations and to maintain a qualified and compliant facility operation status. The Facility & Reliability Engineer will be responsible for the execution of the reliability program and will support the successful operation of facility, laboratory, and business functions at multi-use GMP sites within Client, SummitWest Cell Therapy Operations, through interaction with internal customers and external service providers. The role identifies 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 to recognize problems of moderate scope and complexity and independently develop potential solutions and courses of action. The 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 value knowledge.

KNOWLEDGE, SKILLS, and ABILITIES

• Strong understanding of building systems including life-safety, lighting, mechanical, electrical, plumbing, and HVAC
• Strong knowledge of critical utility systems such as compressed gas, vacuum, waste
• Strong knowledge of and understanding of Computerized Maintenance Management Systems (CMMS)
• Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to prioritize assigned tasks in a high paced GMP environment and concurrently monitor tasks with others that may impact timely completion
• Knowledge of FDA / EU / PDMA / IGJ, GxP environments, ISO, and associated compliance regulations
• Adept in Microsoft Office Suite – Word, PowerPoint, MS Project, Excel, Outlook, and Visio with the ability to learn new software, such as enterprise business, building management, and security
• 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 can work independently without direct supervision and in a cross-functional team environment
• Knowledge of IBC/IFC building codes, OSHA, NFP, FM, LPDS and UL

CORE COMPETENCIES

• Technical knowledge of Reliability Engineering
• Technical Writing
• Problem Solving / Troubleshooting
• Team Player
• Customer Focused
• Action Oriented

Preferred

• Bachelor's degree in mechanical or industrial engineering
• 3+ years of reliability engineering
• 3+ years working in GxP environments
• Lean six sigma knowledge

Required

• 3+ years working in engineering or facilities
• 3+ years working in manufacturing environments

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 procedures.
• Assist in the development and management of a facility document management program to track facility drawings, and project turnover packages.
• 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 application
• 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 of compliance
• Manages any CAPAs associated with the CMMS, including PMs or Calibrations performed late or out of conformance
• Reliability Program: Execute criticality assessments for equipment and components
• Execute FMEA, RCA, and identify alternative options to reduce, mitigate, or eliminate risk
• Performs historical reviews to evaluate the criticality assessment, FMEA and RCA for periodic review
• Continuous Improvement: Reviews completed on-demand work orders for reliability metrics
• Conducts Historical Performance Reviews on GMP Direct Impact assets and critical instrumentation maintained and calibrated by the Engineering & Production Technical Services Department
• 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 and reliability modeling 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
• Promotes and maintains compliance with corporate, safety, security, and regulatory policies
• Maintains all assigned training
• Support the LOTO and Confined Space Entry procedures for GMP Facility owned and maintained equipment