Facility & Reliability Engineer

Job Title : Facility & Reliability EngineerLocation: Summit, NJType: Contract Overview Global Pharma company looking to hire experienced Quality professionals immediately! Must have Deviation Review experience. 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 COMPANYs 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

Requirements

Bachelor of Science in Engineering field or Life Science and or equivalent experience in Facilities and Engineering required

1-2 years of GMP experience required

1-2 years of Cleanroom Certification experience preferred

1-2 years of Reliability Engineering experience at a commercial manufacturing facility preferred

1-2 years of Systems Engineering experience preferred

Lean Six Sigma Training preferred

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

Technical knowledge of Reliability Engineering (criticality assessments, spare parts assessments, reliability metrics, etc.)

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.