Manager Validation

• The Manager/Team Leader oversees the following accountabilities in the assigned unit / department or team:
• Developing new and improved processes for the economical, efficient, and safe chemical/biological manufacture of experimental and bulk active-drug/biological materials
• Preparing large quantities of experimental drug/biological materials for extended analytical, pharmaceutical, biological, and clinical investigations
• Reviewing and resolving issues involving the physical properties of a bulk product to ensure acceptability as required by formulation specifications
• Making recommendations concerning acquisition and use of new technological equipment and materials
• Manages the operational startup of major equipment and or processes by coordinating with Engineering, Operations, and Quality Control/Assurance Management.
• Manages the preparation and approval of validation protocols for critical equipment.
• Reviews final documentation packages for all major validated systems at the plant including, but not limited to utility systems, filling operations, packaging operations, dry heat sterilization/ depyrogenation, steam sterilizers and process washers.
• Manages documentation required for regulatory submissions or responses as required, and assigns support for collection of information as needed.
• Manages Coordination of qualification and re-qualification of manufacturing equipment. Review and approval of Protocols (Installation Qualification, Operational Qualification, Performance Qualifications) and final reports.
• Responsible for preparation and updating of Validation Master Plan for Aseptic and Terminal Sterilization operation.
• Manages project requirements with outside customers and vendors as required.
• Responsible for evaluating/ troubleshooting equipment malfunctions and modifications as related to the Validation, and assigning change control requirements, where applicable.
• Successful accomplishment of requalifications / periodic reviews of equipment according to site policies.
• Successful validation (IQ, OQ, PQ) of all new equipment required to support plant operations.

REQUIREMENTS

• Minimum 4-year degree in a Science or Engineering field of study or combination of education, experience, and training.
• 5 + years of related experience in a cGMP facility

• 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 cGMPs, industry guidance, and aseptic techniques

• Understanding of statistical analysis tools and methods
• Good communication skills and leadership skills are required.

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