Utilities Engineer - Bulk Utilities SME
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Utilities Engineer is responsible for oversight of design, operational and troubleshooting support for the bulk utility distribution systems that include Alcohol Distillation and Recovery Process, Process Gases, Bulk Chemical Distribution (Caustic and Acid solutions for clean in place systems) and Solvent Gas Detection systems with knowledge of associated plant utilities.
The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, automation, quality assurance, validation and project engineering. This individual will work closely with a cross-functional team to meet the needs of the groups they support.
Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the bulk utility systems.
Focus on providing support for existing and new utility systems. Review and make recommendations to management for bulk utility equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
Play an essential leadership role in the operation and troubleshooting of the bulk utility systems.
Serve as the bulk utility subject matter expert. Provides technical expertise for all phases associated with utility/facility systems.
Perform regular field walk-through tours and inspections and initiate any procedures necessary to resolve problems.
Support the planning and execution of activities by working in cross-functional teams. Assist in driving projects to completion to meet timeline and budget objectives.
Continuously stay current with assigned SOPs and keep an up to date training file ensuring compliance with all applicable Standard Operating Procedures.
Collect, analyze and report data for use by the Utilities and Operations department to ensure reliable operation.
Responsible for change controls, CAPAs, risk assessments, Safety and Regulatory Agency Audits.
Provide guidance for support personnel and helps drive development of PM programs.
Prepares User Requirements Specifications (URS), Risk Assessments, Safety Assessments associated with the bulk utilities system.
Participate in validation activities including review of IQ/OQ protocols, executions and summary reports.
Participate in the development and implementation of procedural Standard Operating Procedures (SOPs), technical specifications (Design/Functional/System) and updating P&IDs.
Manage small-scale capital projects, creating scope of work, justification, cost estimates and implementing purchase order requisitions.
Provide support to the Capital Projects Team assisting with equipment submittal reviews, MEP specification and drawing reviews, FAT’s/SAT’s, turnover package reviews ensuring that the documentation is accurate and complete and meets specifications.
Coordinate with site departments to schedule utility system shutdowns, tie-ins and system startup.
Assist with developing predictive and preventative maintenance program for utility systems.
Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, 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.
Bachelor’s Degree in Chemical or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 8+ years of experience in an engineering role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.
Experience working in a Union environment is preferred but not required.
Working knowledge of Process Safety Management and Hazardous Classification/Process Flammable Liquids.
Must have experience with leading mid-to-large capital projects for the pharmaceutical industry.
Experience in new facility start-up, large scale equipment package vendor management, and FAT execution and coordination.
Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry.
Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation.
Working knowledge of pharmaceutical process sanitary connections, valves and supply loops.
Working knowledge of Process Control and Instrumentation for facility control systems. Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., flow, pressure, temperature, level) and controls is required.
Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)
Knowledge & experience in the design, implementation, operations and maintenance of bulk utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA).
Strong knowledge of industry standards and guidelines such as ASME BPE, NFPA, ANSI/ISA standards and CFR’s.
Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP).
Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols.
Experience with Quality Management and Change Control Systems.
Ability to write technical reports and to develop data gathering schedules.
Ability to work on technical specifications and procurement details.
Excellent technical problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision.
Demonstrated ability to work with consultants and contractors, while interfacing with multiple departments, working with internal customers to manage projects, policy, and procedures.
Knowledge of computerized maintenance management systems (CMMS) and utility operations programs. (SAP)
Knowledge of process control systems (Rockwell, Emerson)
Must work and interact effectively and professionally with others.
Must have effective oral and written communication skills.
Computer skills: MS Office Suite, MS Project, and AutoCAD.
Timely Decision Making
Cross cultural sensitivity
Demonstrating CSL Values