The posting
Position Purpose:
The Sr. Utilities Engineer is responsible for oversight of design, engineering, safety, and quality support in the following utility equipment systems:
Clean Steam, Purified Water, WFI and RO Systems, HVAC Systems, Plant Steam Systems, Process Chillers, Compressed/Process Air, Nitrogen, Refrigeration Process, Alcohol Distillation and Recovery Process systems for the Kankakee facility.
This individual will work closely with a cross-functional team to meet the needs of the groups they support.
Main Responsibilities & Accountabilities:
Technical lead accountable for the operational improvement of the utility systems based upon industry trends and emerging technologies:
- Responsible for 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
- Provide technical expertise and industry best practices
- Lead engineering efforts to resolve equipment and operational problems and ensure problem solving techniques are appropriately utilized
- Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments and participates in validation activities including review of IQ/OQ protocols, executions and summary reports.
- Provide technical support to operations, maintenance, manufacturing, automation, quality assurance, validation, reliability engineering and project engineering.
- Support the planning and execution of activities by working in cross-functional teams assisting in driving projects to completion to meet timeline and budget objectives
- Manage system documentation including creation, review, updates, and approval of technical specifications, operating procedures, and system drawings.
Accountable for the Utility Reliability Program:
- Execute the maintenance strategy for new and modified equipment
- Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements
- Develop preventative maintenance procedures for utility systems in collaboration with the Reliability Engineering department ensuring maintenance programs are implemented
- Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts
- Review and lead utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
- Oversees reconditioning of the equipment to restore to like-new condition
- Performs upgrades to improve safety, operational performance, and extend operational life
- Collaborates with local and global partners to develop asset management plan that includes capital requests
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
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
- Review environmental monitoring and laboratory sample release test results
- Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure
- Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production
- Execute root cause analysis during investigations
- Lead investigations as the subject matter expert providing technical expertise for all phases associated with the utility systems
- Responsible for the development and maintenance of the utility drawings, flow diagrams and Standard Operational documents.
- Perform utility inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problems
- Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
- Responsible to ensure training, deviations and investigations related to utility systems have on-time closure and KPI performance metrics are met
- Responsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures.
Support all scheduled capital projects related to utility system shutdowns, tie-ins and system startup.
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.
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.
Additional Responsibilities and Accountabilities (Clean System):
- Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the Clean Utility systems.
- Play an essential leadership role in support of the operation on project support activities.
- Responsible for the Clean Utility generation and distribution systems across the site. These systems include clean steam, purified water, clean air, WFI, clean gases and other ancillary equipment
- Responsible for the quality requirements and the applicable regulatory standards, such as USP, EU and JP.
- Technical lead in engineering, with a focus on pharmaceutical utility systems, industry best practices, and emerging technologies related to utility systems requirements.
Education:
Bachelor’s Degree in Chemical, Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.
Experience:
- 5+ years of relevant experience and a BS
- 3+ years of relevant experience and a MS
- Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)
- Strong knowledge of utility systems (Clean and Plant Utility Systems)
- Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR’s.
- Must have experience with mid-to-large capital projects for the pharmaceutical industry.
- Knowledge of biopharmaceutical process operation and process control, utility and mechanical systems (pumps, valves, materials).
- Working knowledge of pharmaceutical process sanitary connections, valves and supply loops.
- Experience with Quality Management and Change Control Systems.
- Knowledge of computerized maintenance management systems (CMMS).
- Excellent problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision.
- Demonstrated ability to manage contractors, while interfacing with multiple departments, working with internal customers to manage projects.
- Knowledge of manufacturing processes
- Computer skills: MS Project and AutoCAD preferred
Competencies:
- Drives Results
- Customer Focus
- Integrity
The expected base salary range for this position at hiring is $102,000 - $128,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
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 biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
