Serves as the technical lead and supports the specification, installation, utilization, qualification, and improvement of equipment used for assigned manufacturing area.
• Understands the functionality and operation of the equipment.
• Responsible for the current and future design of the equipment/system.
• Accountable for keeping technology current.
• Identifies and implements best demonstrated practices (via Communities of Practice and/or other methods).
• Owns SOP/work instructions for operating system/equipment.
• Develops training and troubleshooting guides.
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).
• Evaluates and updates PMs to keep system performance optimal.
• Implements and monitors predictive maintenance of the system to prevent breakdowns of the system.
• Implements and monitors TPM to ensure the system stays in like-new condition.
Works collaboratively with multiple functional areas such as EHS, Quality, Process Engineering and Manufacturing.
• Ensures the system can be operated safely by the operators.
• Minimizes quality deviations and discards associated with the system.
• Maximizes efficiency/OEE, yield, output, & capacity of the system.
• Updates maintenance and calibration plans collaborating with the expert groups.
Providing data analysis to identify technical changes and replacement investments based on de- bottlenecking and long-term, obsolescence strategies.
• Prevents obsolesce of system parts and components that can impact safety, quality, and reliability.
• Oversees reconditioning of the equipment to restore to like-new condition.
• Performs upgrades to improve safety, operational performance, and extend operational life.
• Develops end-of-life replacement plan for the system to ensure reliable supply to our patients.
• Collaborates with local and global partners to develop asset management plan that includes capital requests.
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.
• 4+ years of relevant experience and a BS
• 2+ years of relevant experience and a MS.
• Strong verbal, technical writing and interpersonal skills are required. Strong communication skills with customers, design teams, contractors, and management
• Action oriented skills; ability to learn on the fly
• Good problem solving, technical learning, time management and prioritizing skills
• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility. Prior experience in pharmaceutical industry is preferred.
• Proficient knowledge of Good Manufacturing Practices (GMPs)
• Audit and Investigation Skills, Report Writing Skills.
• Proficiency in Microsoft Office applications.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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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!