- Manage a team of Principal, Senior and entry-level Validation Engineers whose responsibility is to perform qualification, re-qualification, and periodic review of equipment, processes, and utilities.
- Creates, reviews and maintains validation protocols, reports and related documents ensuring accuracy and completeness.
- Support investigations (OOS, IIR, PIR, etc.) as required.
- Review and update SOPs to ensure appropriate content.
- Ensure that employee training is performed and maintained.
- Support plant in the development of process improvements and efficiency.
- Ensure that the Validation department operates within the budget provided by Senior Management.
- Provide technical expertise and oversight on various technical documents (MBR's, New Product Validation Reports, MCR's, etc.).
- Ensures compliance with FDA and other relevant regulatory requirements and standards 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.
- Responsible for the overall completion of validation studies including reviewing, scheduling, and overseeing the process (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and review/ approve final report preparation.
- Represents the Validation department at the location.
- Overall accountability for ensuring all the equipment meets qualification and re-qualification per regulatory agency standards and company SOPs.
- All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities
- Bachelor's Degree in a Science or Engineering field of study
- 5 + years of related experience in a cGMP facility
- 1+ year of management experience
- Installation, Operational and Performance Qualification protocol generation and execution
- PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency Knowledge and understanding of cMPs, industry guidance and best practices, and aseptic techniques Understanding of statistical analysis tools and methods
- Good communication skills and leadership skills are required.
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Validation Manager - Melrose Park, United States - Fresenius Kabi USA, LLC
Description
Job Summary The Validation Manager is responsible for managing Validation personnel at Melrose Park facility. The individual will oversee validation activities related to equipment and computerized system qualifications and re-qualifications. ResponsibilitiesRequirements
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.
