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!
Supervise the operation and maintenance of all plant utilities systems, clean utilities systems and bulk utilities systems at the Kankakee site. Applies a solid understanding of theories/practices around utility systems toward the effective operations and maintenance of the equipment. Ensures compliance with cGMPs and regulatory requirements.
Responsible for 24/7 utilities operations and production support in the manufacturing plant.
The position requires shift, weekend and holiday work.
- Manage, administer and monitor the hourly personnel assigned to the Utilities Systems area to assure efficient and compliant operation and maintenance of all systems. Performs all scheduling activities to ensure appropriate coverage.
- Facilitate and verify appropriate training for all employees on the shift (including but not limited to cGMPs, job skills, safety, etc.) is up to date. Performs training of direct reports, contractors, and consultants. Responsible for handing out disciplinary action when required.
- Schedules system PM's and coordinates maintenance activities for equipment while minimizing impact on production schedules. Coordinate, oversee and manage contractors as needed to meet the responsibilities of the department.
- Responsible and accountable to maintain equipment in sound condition, report deficiencies and keep the equipment in the assigned area operating in an effective and compliant manner. Maintain the area inspection ready at all times.
- Collects and monitors data to ensure a timely and accurate response to system problems. Elevates cGMP related issues to management and Quality Assurance.
- Ensure compliance with cGMPs and regulatory requirements; provides timely notification to our customers on issues, their causes, duration, and resolution. Troubleshoots and coordinates efforts to keep systems running within defined parameters.
- Key support personnel on equipment failure investigations to ensure timely resolution of any issues thus assuring a continuous supply of utilities and state of compliance with all applicable standards, methods, procedures, licenses and regulations
- Orders supplies and materials required for repairs, PM's, safety, and housekeeping requirements, including but not limited to hazardous materials, caustic, nitrogen, ammonia, bulk salt, process alcohol, nitrogen, sodium hydroxide, HCL etc. Coordinates purchase and deliveries of these materials.
- Coordinates startup, shutdown, and isolation activities within the scope of plant projects, repairs, facility startups, etc.
- Review, author (where applicable) and revise training documents, SOP's, specifications, drawings, etc.
- Identify and support improvements that result in stable, reliable, and efficient operations.
- Track, monitor, assess and report operating and performance data that give insight and indication of the stability and robustness of equipment and systems on an ongoing and forward-looking basis.
- Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as, utilizing the talent management process.
- Provide necessary support to address all compliance issues and to ensure equipment is maintained at a level required to provide high reliability and to maximize useful life.
- Ability to communicate clearly, accurately, verbally and in writing with a strong understanding and knowledge of utilities and maintenance functions.
- Participate and provide support as system owners during regulatory audits.
- Communicates effectively with the Manager on issues and needs of the department.
- 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 an Engineering related field. In lieu of a bachelor's degree an Associate's Degree with a minimum of 5 years of experience. In lieu of a degree a HS Diploma with a minimum of 7 years of supervisory experience in a related field in support of a pharmaceutical, biotechnology or FDA regulated facility.
- Experience working in a Union environment is preferred.
- Working knowledge of Process Safety Management and Hazardous Classification/Process Flammable Liquids is preferred.
- Boiler / Ammonia Certifications is preferred.
- Experience with Trackwise, LIMS, SAP, FMS, KAN MVE, Arriba, DCMS, GDRS, eTime, Plateau preferred.
- Knowledge of USP, cGMPs, European Regulatory requirements a plus.
- Experience working in a GMP controlled environment preferred
- Pharmaceutical Industry experience preferred.
- Strong Communication skills Ability to clearly communicate, both verbally and in writing, to all levels of the organization
- Must be a team player prepared to work in and embrace a team-based culture experienced in operations leadership
- Experience working in a Lean or Value Stream environment
- Experience with Quality Management and Change Control Systems.
- 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 support of manufacturing and facilities equipment.
- Must work and interact effectively and professionally with others.
- Understanding of technical documents such as Maintenance Plans, Task lists, System Specifications (URS, FRS), SAT, FAT, Commissioning & Qualification Protocols & Specifications, Validation Protocols.
- Drives Results
- Customer Focus
- Conflict Management
- Timely Decision Making
- Time Management
- Cross cultural sensitivity
- Demonstrating CSL Values