Systems Owner, Bulk
The person in this role will have the responsibility for a machine or group of machines (system) to ensure it continues to meet the needs of CSL Behring internal customers. The focus of this role will be to directly drive improvements, reduce wastes, and apply engineering principles/knowledge within a manufacturing department to continuously improve safety, technical compliance, and equipment/process reliability.
Serves as the technical lead and supports the specification, installation, utilization, qualification, and improvement of equipment used for assigned manufacturing area.
Ensure the technical reliability as well as the safety of production facilities in the assigned manufacturing department. Work to improve equipment reliability as measured by Operational Equipment Effectiveness (OEE).
Works collaboratively with multiple functional areas such as EHS, Quality, Process Engineering and Manufacturing.
Providing data analysis to identify technical changes and replacement investments based on de- bottlenecking and long-term, obsolescence strategies.
Ensure equipment and processes are compliant with the government regulations. Acts as equipment
SME during internal or external Regulatory inspections.
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.
Completes any other duties/responsibilities assigned by senior management.
Requires a Bachelor’s Degree in Mechanical, Chemical or Manufacturing Engineering or equivalent degree may be considered dependent upon experience.
4+ years of relevant experience and a BS
2+ years of relevant experience and a MS.
Prior experience in pharmaceutical industry is preferred.
Proficient knowledge of Good Manufacturing Practices (GMPs)
Audit and Investigation Skills, Report Writing Skills.
Strong verbal, technical writing and interpersonal skills are required.
Proficiency in Microsoft Office applications.
Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!