This position is a technical leader in the utility engineering team with overall accountability for reliability in Clean and Plant utility operations and maintenance at the CSL Kankakee Site.
Implement strategy in alignment with functional goals and Engineering objectives. Develops key objectives in support of the Utility Engineering, Operations and Maintenance Program.
This individual will work closely with a cross-functional leadership team to meet the needs of the groups they support.
Directs a team of engineers and is accountable for the operational improvement of the utility systems based upon industry trends and emerging technologies:
- Provide strategic leadership and guidance in compliance and operational improvement of equipment systems.
- Provide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life
- Implement measures to improve equipment that support utility operations.
- Participate in leadership meetings providing technical support in all matters pertaining to engineering, operations and maintenance of the equipment systems.
- Provide technical expertise and industry best practices
- Support commissioning and qualification activities
- Lead troubleshooting efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilized
- Ensure client provides uninterruptible utility services and urgent matters are addressed in a timely matter
Accountable for the Site Utility Program:
- Provide leadership and technical expertise for maintenance strategy for new and modified equipment and systems
- Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements
- Continuous Improvement of SOP’s, maintenance PM’s, BOM’s and Spare Parts
- Ensure 100% Utilities Equipment uptime providing technical support to utility operations and maintenance.
- Works on problems of complex scope where analysis of scenarios or data involves multiple competing factors
Manage and monitor KPI’s:
- Ensure compliance with site and global indicators
- Measure and ensure compliant performance in Safety, Quality and Reliability
- Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics
- Utilize control systems to monitor, trend and verify equipment performance and downtime
- Maintain metrics to measure performance against business objectives and make necessary changes to improve performance
Ensure cGMP compliance of all utility systems to meet regulatory compliance:
- Equipment is maintained at a level required to provide high reliability maximizing useful life
- Oversee environmental monitoring and laboratory sample release test results
- Ensure all staff is adequately trained on work related duties and up to date on all regulations and environmental guidelines.
- Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure
- Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production
- Peer review root cause analysis around equipment and operational events, support complex change controls, investigations.
- Lead complex investigations using Root Cause analysis capability
- Partner with Quality and Environmental Health and Safety team to ensure compliance
- Responsible for Process Safety Management and Hazard Reviews (PSSR’s, PHA’s, etc)
- Responsible for the development and maintenance of the utility master plan, drawings, flow diagrams and Standard Operational documents.
- Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
Responsible to develop, maintain and continuously improve strategic plans:
- Utility Systems Regulatory Program
- Utility Campus Load Profile
- Utility Roadmap
- Utility Business Continuity Strategy
- Maintenance Execution Strategy
- Mechanical Integrity Program
- Pressure Vessel Program
Supports development and execution of the site master plan, budget and operating expenses.
Responsible to address all safety related events and ensure operations and maintenance team is adhering to the safety policy.
Collaborates within the CSL network to share best practices.
Provides technical support, cost estimates and budgeting for utility modifications, upgrades and capital projects.
Responsible for development of the department, placing a high priority on developing others through coaching, feedback and developmental goals where team members experience personal and professional growth.
Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities.
Primary Technical Representative for Internal and Regulatory Agency audits.
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.
- Bachelor’s Degree in Chemical, Mechanical or Electrical Engineering preferred or B.S. degree in an Engineering related field.
- 7+ years of relevant experience and a BS
- 3+ years of relevant experience and a MS
- Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards, CFR’s and Process Safety Management.
- Strong knowledge & experience in the design, installation, operations and maintenance of Clean and Plant utility systems
- Knowledge of building management systems (Emerson, Rockwell, Metasys)
- Knowledge of technical documents such as Maintenance Plans, System Specifications (URS, FRS), SAT, FAT, Commissioning / Qualification Protocols & Specifications, Validation Protocols.
- Proficiency in Power BI is a plus
- Experience with Quality Management and Change Control Systems.
- Knowledge of computerized maintenance management systems (CMMS).
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
- Knowledge of manufacturing processes
- Strong Leadership skills
- Financial experience with high level budgetary responsibilities
- 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.
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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.
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