This position is responsible for the equipment reliability and maintenance strategy of utility and manufacturing equipment through continuous monitoring of equipment operational performance and implementing actions needed for improvement (Reliability-Centered Maintenance).
Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA), root cause failure analysis (RCFA) and failure reporting, analysis, and corrective action system (FRACAS).
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.
Qualifications:
• 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
•Certified Maintenance & Reliability Professional, (preferred but not required)
•Certified Reliability Engineer, (preferred but not required)
•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).
•Prior experience in pharmaceutical industry is preferred.
•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.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
