GMP Facility Coordinator
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!
Key contributor and technical support in team activities associated with maintenance, continuous improvement and capital projects related to the operation and maintenance of the Cell and Gene Therapy Clinical Manufacturing Facility and R&D Laboratories
The ideal candidate technical skills in pilot scale manufacturing facility plant/equipment operations, a complete understanding of, and stringent compliance to, GxP, with an understanding of engineering concepts.
1. Ensure all maintenance work (routine and non-routine) in CSL R&D laboratories and Manufacturing Areas by third party contractors is carried out according to approved procedures and safety guidelines (including site induction). Ensure that appropriate preventative maintenance and repairs to critical equipment occurs in a timely manner. (Contractor/Vendor management)
2. Assist the troubleshooting of R&D non-GMP and GMP processes and plant, where possible perform root cause analysis of breakdowns and implement proactive programs (eg reliability centered maintenance, operational excellence, six sigma) to minimize future downtime.
3. To support the Operational support team, including assist in plant shutdowns, start-ups and maintenance interventions. Respond to in-hours and out-of-hours alarm calls. Occasionally assisting other team member (e.g. assisting in validation activities or cleaning scheduling).
4. Ensure assets in Computer Maintenance Management Systems (CMMS) is maintained and accurate. Ensure maintenance work orders are completed per site procedures.
5. Ensure high safety standards within the areas of responsibility are taken into account and adhered to as governed by local, state and federal regulations, laws and policies as well as CSL’s policies and directives
6. Assists in developing and updating operational SOP’s and engineering documents
7. Develop relationships with other CSL locations to harmonize and improve site systems and implement best practices
8. Supports management the facility in internal and external (regulatory/vendor) inspections
9. Be flexible and adaptable to changing work place priorities, as required for the sites R&D pipeline development.
10. Completes any other duties/responsibilities assigned by senior management.
11. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
12. Stay current on industry trends by reading trade journals, attending trade shows, attending industry-training seminars and visiting other pharmaceutical companies.
- BS degree with a concentration in Engineering or Science preferred
- At least 2-5 years’ experience in pharmaceutical or laboratory environment ideally with exposure to development of new products
- Understanding of cGMP and FDA regulated environments. Knowledge of and familiarity with other plant operations, such as Manufacturing, QC/QA, etc.would be preferred
- Excellent computer skills and willingness to learn new programs. Including MS Office, MS Project and MS Visio.
- Understanding of Biopharmaceutical and/or Pharmaceutical manufacturing and Quality processes, including GxP validation principles.
- Understanding of Computer Maintenance Management Systems (CMMS)
- Knowledge and experience with SAP ERP system. Understanding of Plant Maintenance (PM) management principles preferred
- Possess excellent interpersonal skills, both verbal and written. Must be able to communicate effectively with all levels of management and staff
- Strong customer focus with commitment to high quality outcomes
- Mechanical aptitude and familiarity with engineering drawings and specifications.
- Understanding of instrument calibration systems and management highly desirable
- Experience with clean room facilities and practices
- Awareness of various regulatory guidance’s such as PIC/s, FDA, EMEA and ICH
- Task and team oriented, analytical, organized, detail-oriented, self-motivate and able to multi-task
- Ability to work in a fast-paced and changing environment
- Ability to lift or carry up to 40 lbs.
- Ability to stand for prolonged periods of time
- Frequently required to wear personal protective equipment
- Occasionally exposed to hazardous chemicals and to blood borne pathogens