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!
Establish and execute strategic direction for site engineers in alignment with site goals.
Transform existing operational practices to leverage tools, processes, relationships, best practices to ensure service delivery is high efficient and effective.
Manage all aspects site engineering duties within a functional area that provides technical, project, emergency response, troubleshooting and maintenance support for relevant equipment and/or systems
Develop policies, procedures and guidelines to ensure facilities are designed, operated and maintained in a manner that ensures compliance with GMP, FDA, HS&E, Local, State and National laws/ regulations /policies & procedures.
Develops and recommends strategic maintenance and routine qualification approach for the Manufacturing, Maintenance, and Engineering & Utilities Teams.
Assurance that qualification plans are performed according current standards and guidelines
Oversees investigation of deviations in the context of deviation management and establishment of corrective actions and preventive actions regarding critical systems
Responsible to support the engineering and project management in themes of risk analysis, qualification activities, metrology, data integrity plus general GMP issues as well as in the preparation of documentation.
Develops and recommends metrics for the site engineering objectives
Leads and monitors Key Performance Indicators (KPI), the development and implementation of short, medium and long term goals and objectives to achieve operational readiness for each project. Ensuring projects successfully pass through each stage gate.
Oversee Regulatory Compliance and Quality Assurance to ensure the functional area stays in compliance
Leadership of the management team of ES
- Ensure projects, services and projects are in compliance with GMP
- Encourages a culture of continuous improvement and development of cGMP, services and technologies within QMES.
Places a high priority on developing others through coaching, feedback and developmental goals.
Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency 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.
Represent functional area in regulatory audits
Completes any other duties/responsibilities assigned by senior management.
Bachelor's Degree in Engineering or related field
• Bachelor's degree and 6 years of manufacturing equipment maintenance experience
Master's degree and 4 years of manufacturing equipment maintenance experience
• Expertise in GMP/non-GMP Utilities and Facilities related to pharmaceutical production required
• Analytical problem solving
• Knowledge of conflict resolution and negotiating skills
• Ability to partner with other departments or functional areas
• Experience managing a union workforce preferred
• Customer Oriented
• Must be computer proficient in the use of the many programs required to operate and manage facilities - Trackwise, SAP, FMS, Ariba, DCMS
• Knowledge of Six Sigma / Lean principles a plus
• Advanced skills in MS-Project, MS-Excel, MS-Word, MS-PowerPoint, MS-Visio, and MS-Outlook
• Advanced skills Power BI, Smart Sheet or Tableau
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.