Experiences at Bayer Healthcare

Responsible for managing the filling and freeze-drying area annual requalification program, including scheduling, protocol generation, execution, analysis of test results, preparation of summaries, and managing activities assigned to junior personnel. Train new hires. Review and approve protocols and reports prepared by peers. Perform engineering check out, installation, operational, and performance qualification of equipment (sterilizers, freeze-dryers, vacuum verification system, etc.), utilities (WFI, microbial air system), and facilities (cold room, incubator room) in the filling, freeze-drying and packaging area. Perform process qualifications for aseptic processing, lyophilization, and sterilization including design and execution of the studies. Prepare technical reports for submission to regulatory agencies. Present validations to regulatory authorities during inspections. Represent the department on cross-functional project and validation consistency teams. Write new and revise existing SOP's and BPR's. Instituted cGMP compliant method for sterilization validation for the entire site. Work extensively with Kaye (Digistrip and Validator 2000) equipment....

enMaintained the existing building WFI system. Validated a new building WFI system (performance qualification). Investigated discrepancies associated with the WFI system, clean steam, cold rooms, and equipment in the plasma area. Wrote new and revised existing SOP's and P&ID's. Ordered new equipment for the plant per engineering standards (tanks and analytical equipment). Performed engineering check out, installation, and operational qualification of the new equipment. Assisted validation personnel in performing validation activities....

* Coordinate and negotiate meetings and/or community events on or off site
* Assist in development, implementation, and monitoring of internal operating systems and procedures
* Conduct comprehensive investigation into issues, then developed and implemented solutions to address those issues.
* Facilitate cross-functional communication with Directors to achieve objectives
* Proactively addressed inter-personnel disputes in a professional manner to maintain a cooperative work atmosphere
* Use a systematic decision-making approach to research, analyze, and provide feedback on issues, policies and procedures
* Prepare KPI reports and other documents, without direction, using independent thought and a thorough understanding of key information elements that needed to be communicated
* Use independent judgment to plan, prioritize, and organize diversified workloads for self and other individuals.
* Consistently balance multiple projects, ensuring that actions are aligned with priorities
* Responsible for the progress of small to medium sized projects, which included multiple components and determined milestones and deadlines
* Member of the Employee Survey: Leadership Skills Team...