MS&T and Validation Lead (m/f/x)

About the role

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: 1 MS&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: Manufacturing Finance Quality Assurance Quality Control Regulatory Affairs Supply Chain Technical Operations Site & Global Functions 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. 2 Process Technology Responsibilities and Accountabilities: Leads multi-disciplinary project teams through life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements. Develops Process Automation Strategy for project activities. Works closely with Automation teams to ensure that project instrumentation, automation, and alarm strategies align with industry standards and with product Quality by Design approach. Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval. Ensures that initiatives are aligned with the business objectives and strategic philosophy. Oversees project teams responsible for completion of project lifecycle activities through turnover to routine commercial production. Oversees generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for senior site management and Global Steering Committees. 3 Validation Responsibilities: Assessment of Validation Requirements for Site Projects. Responsible for providing Validation Support and Staffing for Site Projects. Accountable for ensuring that all Manufacturing Processes on site remain in a Validated State, including Cleaning Processes. Responsible for providing adequate Staffing for routine/regularly recurring Validation activities Oversees writing and reviewing of documents for required registrations and providing adequate responses to regulators regarding validation topics. Responsible for leading and performing Process Risk Assessments for the Site Manufacturing Processes using defined Risk Management tools. Responsible for providing input to Deviations related t

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at CSL? Share your experience