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Company

BioSpace · 2 days ago

Reliability Engineer

Illinois, United States

Full-time

Remote

Mid Level

3+ years exp

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Comp. & Benefits

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Responsibilities

Serves as the technical lead and supports the improvement of equipment in the plant.

Develop, implement and maintain equipment maintenance strategy and plans for plant equipment.

Perform continuous improvement of maintenance PM’s, BOM’s and Spare Parts in support of compliance with applicable regulations

Recommend and implement measures through global initiatives to improve equipment that support utility and manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment.

Provide engineering field support to identify, address and resolve operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life.

Collaborate with Engineering in the equipment classification process, defining SAP Location hierarchy, populating asset information, developing Return-to-Service PM instructions and acquisition of equipment manuals.

Conduct analysis of system maintenance process and perform reliability studies:

Use of reliability tools and processes such as Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA)

Uses data to recommend improvements based on CMMS, FMEA, RCA and systems reliability data

Analyze equipment trends ensuring the maintenance program is effective

Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements:

Ensure that the Preventative / Predictive Programs and Maintenance Planning Processes are executed

Evaluate new technologies (predictive tools) to be used by technicians and engineers

Accountable to effectively apply PdM technologies and non-destructing testing to minimize unscheduled/scheduled maintenance downtime

Monitor KPI’s

Measure and report reliability performance

Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics

Subject Matter Expert (SME) for Internal and Regulatory Agency audits.

Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability.

Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance

Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.

Completes any other duties/responsibilities assigned by senior management.

Qualification

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Mechanical EngineeringReliability EngineeringPharmaceutical cGMP UtilitiesRoot Cause Analysis (RCA)Failure ModesEffects Analysis (FMEA)Six SigmaComputerized Maintenance Management Systems (CMMS)Manufacturing Practices (GMPs)Certified Maintenance & Reliability ProfessionalCertified Reliability EngineerVibration AnalysisUltrasound ScanningInfrared ScanningOil AnalysisEddy Current TestingDynamic/Static Motor Current TestingMS Office SuiteMS ProjectAutoCADTechnical Writing

Required

Bachelor degree in Mechanical, Process or Chemical Engineering preferred or B.S. degree in an Engineering related field

3-5 years' experience with pharmaceutical cGMP utilities plant including Clean room, HVAC, water system, pure steam systems and critical gases

Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma.

Experience in Vibration Analysis, Ultrasound Scanning, Infrared Scanning, Oil Analysis, Eddy Current, Liquid Penetrating testing, Dynamic/Static Motor Current testing, etc

Knowledge of computerized maintenance management systems (CMMS).

Proficient knowledge of Good Manufacturing Practices (GMPs)

Strong verbal, technical writing and interpersonal skills are required.

Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.

Computer skills: MS Office Suite, MS Project, and AutoCAD.