The Utilities Manager plays a pivotal role in ensuring the availability and GxP compliance of media supply systems.
Responsibilities include:
* Ensuring the reliability and quality of high-purity media supply systems
* Planning, coordination, and implementation of timely data analysis for high-purity media monitoring results
* Creation of associated trending reports to identify areas for improvement
* Initiating corrective actions in case of abnormalities or deviations
* Trend analysis of GMP alarm messages to maintain process stability
* Creation and editing of Deviation Records, Changes, CAPAs as an owner in Veeva
* Defining sample train locations, including rationales and risk analyses
* Defining sample train frequencies, including rationales and risk analyses
* Coordinating special sample combinations for qualification or deviations
* Implementing measures and quality checks after work on high-purity media systems
* Utilizing electronic systems for planning and documenting tests
* Trend evaluations and storage of data (PI, SAP, MIS, ELVIS, SingleLIMS, BO, PK system)
* Regular review and adjustment of warning limits to ensure process control
Requirements:
* Fluent German language skills
* Bachelor's or Master's degree in a scientific field with several years of professional experience
* Initial experience in media supply, cleanroom, and zone concept, high-purity media monitoring
* Initial experience in the GMP & Pharma sector
* Strong IT skills (e.g., Microsoft, Google)
This is a mid-senior level contract position in Quality Assurance within the Biotechnology Research and Pharmaceutical Manufacturing industries. It offers opportunities for trend analysis, problem-solving, and collaboration to maintain process excellence and ensure product quality.