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

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 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 to Validation activities: support of the root cause analysis and CAPA definition as required.
• Identification and closure of Validation Gaps on site to minimize Compliance Risks.
• Key point of contact in Regulatory Inspections for all Validation topics.
• Accountable for tracking key Validation KPIs on site.

4 Management Responsibilities and Accountabilities

• Directly oversee technical staff with expertise in several differing technical disciplines supporting multiple Manufacturing Facilities and Value Streams.
• Responsible for development of staff, including motivating in a manner that promotes the achievement of CSL’s business goals and objectives.
• Establish performance goals and strategic/operational objectives for team.
• Coach, counsel, and appraise performance of personnel.
• Develop staff competencies & capabilities to enable business continuity, sustained success, and career development.
• Promote high employee engagement and a positive work environment.
• Responsible for organizational design, resource requirements, and staffing decisions. Recruit, retain, train, and develop the team.
• Capable of influencing site and global leadership.
• Able to manage partnerships both internally and externally.

Position Qualifications and Experience Requirements

1 Education

• Undergraduate/graduate degree in Engineering or related technical field

2 Experience Required

• 10+ years working in Engineering, Process Development, or Validation of biopharmaceutical products and processes in Pharmaceutical, Chemical Manufacturing or similar industry.
• Demonstrated experience in process monitoring, analytics, and improvement development & execution.
• Strong communication, negotiation, and conflict management skills to influence technical experts and stakeholders including non-specialists, at all levels in the organization.
• Demonstrated experience in managing, organizing, developing, and deploying best practice frameworks, processes, tools, and templates.
• 5+ years of experience managing and working within a global matrix organization.
• Involvement in cross-functional, multicultural, and international teams.
• Must have a strong understanding of biopharmaceutical operations and relevant GMP regulations and regulatory guidance.