Danaher Corporation Cleaning Validation Manager in Fargo, North Dakota
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Technical Operations Department located in Fargo, ND and will be on-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Process Validation Team and report to the Sr. Manager of Process Validation and Characterization responsible for oversight of all Cleaning Validation and Disinfectant Efficacy qualification activities at the Aldevron, Fargo manufacturing site. This role will work collaboratively with internal and external stakeholders to manager complex timelines and meet customer expectations for Validation activities. This position will directly oversee the teams performing cleaning validation and disinfectant efficacy qualification.
Provide strategic development and continuous improvement of the Cleaning Validation Master Plan and Disinfectant Efficacy Master Plan.
Develop and manage a Continued Process Performance Verification program for validated cleaning processes and track production data.
Bachelor’s degree in chemistry, statistics, or science-based discipline with 5+ years of experience in pharmaceutical or life sciences industry
5+ years of analytical method development, validation, and/or manufacturing experience
Help to resolve quality issues and CAPA’s by assisting with lab investigations, conducting root cause analysis, and developing implementation plans.
Schedule resources and personnel to achieve department and company goals.
Ability to lead in a strategic and analytical manner, with a strong ability to translate these and implement operationally.
Support design and execution of ancillary experiments to establish cleaning processes and acceptance criteria.
Provide technical support during client and regulatory agency site audits.
Support of additional areas of Validation as needed (ex. Process, Stability, Method, Systems) by authoring, reviewing, or approving protocols or standard operating procedures (SOP’s).
Experience working at a CDMO is a plus.
Experience with cleaning validation, cGMP manufacturing, and Quality systems within a regulated environment.
Experience with upstream and downstream bioprocessing unit operations for large molecules.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
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