Scientist Process Manufacturing
Lead or provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits. Drive and/or coordinate process improvements, utilizing the change control system as required. Generate and analyze trend reports on production processes and track effectiveness of changes. Support a strong cGMP environment.
1. Provides technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits.
2. Analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluates information relating to process conditions and assesses their state of control. Generate and analyze trend reports on production processes and track effectiveness of changes. Communicate this information to department personnel and site management on a routine basis.
3. Utilize project management skills to track progress of projects to ensure milestones are met.
4. Drive process improvements and coordinate document changes (DocNet). Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set.
5. Provide (statistical) data/analysis to support groups including: Quality Operations, R&D, Regulatory Affairs, Microbiology, Engineering and Validation.
6. Stay current on industry trends by reading trade journals, attending trade shows, attending industry training seminars and visiting other pharmaceutical companies.
7. 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.
8. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
9. Complies with requirements from CSL Behrings Safety Program, including Health and Safety mandates and OSHA requirements.
10. Completes any other duties/responsibilities assigned by senior management.
Requirements:
Education: BA/BS in a scientific or technical discipline preferred. Strong academic analytical/statistical mathematical background desired.
Experience: With a BS/BA in a scientific or technical discipline, 3+ years in a pharmaceutical manufacturing and/or laboratory environment. With a BS/BA in another discipline, 5+ years in a professional role within a pharmaceutical manufacturing environment.
Worker Type:
Employee
Worker Sub Type:
Regular
