Manager Clean Utility Systems
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 purpose of this position is to manage all activities, all personnel related to the establishment and operation of the clean utilities systems (Clean Steam, Purified Water, Process Air, WFI and RO Systems) for the Kankakee facility.
The Manager is responsible for supporting cGMP operations by providing technical support and troubleshooting for the clean utility operations and associated equipment. The responsibilities include support of the day to day operations of the department, overseeing and support of projects and long-term implementation of equipment lifecycles. This individual will work closely with a cross-functional team to meet the needs of the groups they support.
Provide supervision of staff, including hiring, training, personnel development and performance reviews, planning, assigning and directing work, rewarding and coaching, addressing and resolving problems.
Provide leadership and guidance in compliance and operational improvement support of the Clean Utility systems.
Lead department operations and performance to drive efficiency.
Provide necessary support to production and facility personnel to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life.
Actively identify multiyear equipment replacement needs.
Provide technical expertise and industry best practices to the department supporting GMP process manufacturing equipment and utilities.
Support the design, implementation and commissioning for new equipment and/or modifications to existing equipment.
Perform investigations of deviations and anomalies related to the failure of the utility systems using Trackwise and other Quality Management systems.
Review drawings and designs for adherence to established specifications and standards.
Ensure 24/7 support to troubleshoot, identify and resolve utility equipment issues.
Manage, motivate, and mentor the staff to continuously improve skills and team performance. Lead by example, recognize and celebrate successes.
Organize and prioritize staff and workload to meet or exceed productivity metrics. Ensure all staff is adequately trained on and act in accordance with cGMP, quality, and safety standards.
Work and interact effectively with cross-functional teams, including Facilities, Engineering, Quality, and Manufacturing
Manage routine equipment repair and maintenance, obtain proposals/quotes from vendors/contractors for work done by the department.
Ensure project/department milestones/goals are met and adhere to approved budgets, including contracted services.
Technical Representative for Regulatory Agency audits.
Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational excellence methods and tools to improve the overall efficiency of the department and the elimination of "non-value added" activities.
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 or Mechanical Engineering preferred or B.S. degree in an Engineering related field, with 5+ years of experience in an engineering role, 1+ years of experience in a management role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility.
Experience working in a Union environment is preferred.
Knowledge of CIP/SIP, clean room design/requirements.
Strong knowledge of industry standards and guidelines such as ASME BPE, ISPE Baseline Guides, USP, EU GMP, ISO standards and CFR's.
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, conductivity, UV) 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 clean utility systems, as well as working in a regulated environment (FDA, cGMP, OSHA).
Experience with architectural, MEP and P&ID drawings preferably in the pharmaceutical industry.
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.
"Hands-on" approach in managing support of manufacturing and facilities equipment.
Demonstrated ability to manage 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 building management systems (Emerson, Rockwell)
Must work and interact effectively and professionally with others.
Must have effective oral and written communication skills.
Understanding of technical documents such as Maintenance Plans, Task lists,
System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification
Protocols & Specifications, Validation Protocols.
Computer skills: MS Office Suite, MS Project, and AutoCAD.