SR MANAGER, VALIDATION

• Responsible to establish the Validation strategy for new processes/equipment and translates those requirements to appropriate validation protocols and standard operating procedures
• Develops, maintains, and updates the Validation Master Plan (VPM) for the overall project
• Ensure that Validation Department conducts in accordance with current Good Manufacturing Practices, the company's quality goals and sustainable compliance initiatives, as well as the company's mission, vision, and values
• Oversees activities of the project personnel to include assignment of tasks, scheduling, and coordination across the various plant functional areas
• Responsibilities for qualification of new equipment/processes, computer-related system qualification and calibration program management
• Reviews detailed plant layouts, procedures, and equipment specifications (URS) to ensure the project progress and regulatory compliance
• Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA), maintaining compliance within the company
• Communicates and reports the status of each project to the management and department that sponsors the project. Communication includes project status, milestones, and any additions to the scope of the project as well as regular updates in the form of written reports and oral presentations to senior management
• Works as part of a multi-disciplined team
• Directs validation projects by coordinating contractors or site personnel, reviewing the generated reports, and implementing any changes or recommendations that result from the studies
• Revise, review, and approve existing SOPs and develops new SOPs for systems/equipment
• Manage creation of execution and adherence to the Departmental Budget
• Mentors and develops staff regarding teamwork, validation techniques and procedures to ensure cGMP compliance
• Communicates metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations
• Interfaces with the FDA or other regulatory body relative to equipment and control system issues or critical processes as the primary Validation interface (SME)
• Ensure department personnel are aware of Fresenius Kabi's Environmental and Energy Management

• System including Environmental and Energy Policy.

• Responsible for ensuring that Health, Safety and Environmental requirements are met under the requirements of ISO 14001 Environmental Management System and ISO 50001 Energy Management System.
• Supports the needs of a 24 hour production facility

• REQUIREMENTS

• Bachelor's degree in science or engineering field or a combination of education, training, and experience.
• 10 years of related experience in a cGMP facility
• 5 years of leadership experience with direct reports
• Experience in cGMP CA/PA, root-cause analysis, risk assessment, and investigation tools and techniques
• SME oversite of all disciplines within Validation: Commissioning and Qualification (IQ/OQ/PQ), Sterility Assurance, Cleaning Validation, Computer Systems Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique
• Current knowledge and understanding of cGMPs, industry guidance, and aseptic manufacturing, room classifications and airflow pattern testing tools and techniques, depyrogenation/sterilization requirements and techniques and associated statistical analysis tools and methods.
• PC literate with standard Office application (Word, Excel, PowerPoint, Project, Access)
• Previous experience and participating in with FDA, EU, ICH regulatory agency inspections
• Must have excellent verbal skills. The ability to communicate clearly and extemporaneously to a variety of audience types, included regulatory agencies.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.