Manager Validation

Fresenius Kabi•Wilson, NC

About The Position

Oversees the development and improvement of chemical and biological manufacturing processes for drugs and biological materials, while addressing issues related to the production scale-up and ensuring compliance with formulation specifications. Salary Range: $90,816-$126,991 Position is eligible to participate in a bonus plan with a target of 10% of the base salary. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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.

Responsibilities

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.