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 operational and troubleshooting support for the utilities Building Automation System (BAS) with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Experience with other automation platforms is a plus.
Will provide plant engineering support for Tier projects as it relates to the BAS control system.
Will demonstrate skills in design, configuration, integration, implementation, and qualification of control solutions specific to HVAC via Johnson Controls Metasys for Validated Environments with integration to OSI-Pi historian.
The Engineer will serve as a lead for utilities engineering between operations, maintenance, manufacturing, 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 building automation systems.
Review and make recommendations to management on automation component replacement as part of the life cycle improvement process and continuous improvement initiative planning.
- Play an essential leadership role in the operation to troubleshoot and diagnose automation control system problems utilizing technicians and external resources on project and operational support activities.
- Serve as the subject matter expert. Provides technical expertise for all phases associated with the automation system, provides improvements based on supporting data, technical knowledge, engineering principles and current industry practices.
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 as the Engineering lead/representative for the utilities automation area.
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 Operations and Engineering department to ensure reliable operation.
Perform event's investigation related to utilities automation system and implement the corrective and preventive action required to address the event. 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 automation system. Perform and document hardware/software modifications, and system functional specification updates.
Design and implement changes to BAS control systems while adhering to pharmaceutical validation and change control standards. 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.
Competent in all aspects of Johnson Controls Metasys for Validated Environments software configuration tools. Understands coordination and communication protocols between platforms such as Allen Bradley, MODBUS, BACNet, etc.
Perform and document hardware/software modifications and system functional specification updates.
Coordinate with site departments to schedule automation shutdowns, tie-ins and system startup.
Assist with developing predictive and preventative maintenance program for the automation 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 an Engineering related field, with 5+ years of related automation/controls 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.
- Strong programming/design "hands-on" experience with Building Automation System (Johnson Controls, Siemens, Honeywell, Rockwell, or other) and SCADA systems is required.
- Experience configuring, troubleshooting and using Windows Operating Systems, Networking, virtualization and Databases for Control System Applications
- Experience with data historians (like OSI-PI), MS-SQL and reporting tools are required.
- Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry.
- Be knowledgeable with respect to HVAC systems (air handling units, return fans, exhaust fans, air terminal devices, diffusers, grilles, refrigeration cycles and other air moving processes).
- Be knowledgeable with respect to hydronic systems and air balancing methods.
- Must have experience with executing test protocols for Freezer Coolers, Incubators, Clean Room Environments and HVAC Equipment in a FDA Regulated Environments.
- Knowledge of biopharmaceutical process operation and process control, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation.
- Knowledge of clean room design/requirements. Working knowledge of pharmaceutical process sanitary connections, valves and supply loops.
- Working knowledge of 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 automation control utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA).
- Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, ISO standards and CFR's.
- Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP).
- Experience with Quality Management and Change Control Systems.
- Ability to write technical reports and to develop data gathering schedules.
- 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)