MS&T and Validation Lead (m/f/x)
R-282095
Full-time / permanent/ Level 9
The MS&T and Validation Lead is accountable for defining Strategy and leading Execution of Technical Process Support for the Site’s Manufacturing Value Streams (Base Fractionation, Bulk, Aseptic Filling, Visual Inspection, and Packaging). This role leads a cross-functional team of technical experts responsible for MS&T, Process Technology, and Validation. The MS&T and Validation Lead will manage all cross-functional resources in a matrix fashion which maximizes agility, fungibility, and efficiency across disciplines.
In the area of MS&T, the team will provide Process Expertise in all Unit Operations associated with Plasma Fractionation, Bulk Purification, Formulation, Aseptic Filling, and Packaging Manufacturing activities for parenteral products. This team provides Process Expertise to the Site’s 24/7 Manufacturing Operations. The team also works closely with Finance, Quality Assurance, Quality Control, Regulatory Affairs, Sterility Assurance, Supply Chain, and the other Technical Operations Site and Global Functions.
In the area of Process Technology, the team will provide Process Expertise to all site CAPEX and OPEX projects. The Process Technology team is responsible for ensuring that Site Projects properly scope, develop, procure, construct, and qualify new equipment and facilities which maintain Regulatory Compliance while achieving Manufacturing Design Capacities.
In the area of Validation, the team will provide Strategy and Execution of all Site Process and Cleaning Validation activities. The Team ensures that Validation for all Site Projects is executed in compliance with Company Standards and Global Regulatory Requirements. The Validation Team also ensures that Routine Plant Operations are maintained in a Validated State.
Main Responsibilities and Accountabilities:
1MS&T Responsibilities and Accountabilities:
Provides Process Expertise in all Unit Operations associated with Plasma Fractionation, Bulk Purification, Formulation, Aseptic Filling, and Packaging Manufacturing activities for parenteral products. This team provides Process Expertise to the Site’s 24/7 Manufacturing Operations. Provides Technical Expertise in MS&T, Process Technology, and Validation for the Site’s 24/7 Manufacturing Operations across each Value Stream and Facility.
Develops and maintains diverse collaborative network to enable comprehensive ongoing technical support of manufacturing issues and improvements:
Provides deviation Technical Assessments, Justifications, Investigations, and determination of Corrective and Preventive Actions (CAPAs).
Provides technical leadership of site and global Taskforces to resolve business critical and/or complex deviations and issues.
Partners with global teams to improve network Process Robustness through process monitoring, “Quality by Design” (QbD) life cycle management, and global process/technology design standardization.
Promotes a collaborative and inclusive environment while driving a culture of high performance, sense of urgency, action-orientation, and mutual accountability.
2Process Technology Responsibilities and Accountabilities:
3Validation Responsibilities:
4Management Responsibilities and Accountabilities
Position Qualifications and Experience Requirements
1 Education
2 Experience Required
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .
Our Benefits