Quality Control Laboratory Senior Engineer
Xellia

Job Duties:

Author and execute Installation, Operational and Performance Qualification protocols for laboratory instruments like density meters, pH/Conductivity meters, Karl Fischer Titrator, Microdilutor, Sterilizer, etc. and perform temperature mapping studies for equipment like Refrigerators, Freezers, Incubator, Walk-In cold room and warm room within Quality Control Laboratory. Provide validation support by reviewing User and Functional Requirements, Validation Plans, Components Impact Acceptance, and Project Scope for QC laboratory projects. Evaluate instruments, laboratory equipment and processes for recommended improvements that will eliminate the potential for failures & deviations. Analyze and review validation test data to determine whether systems or processes have met validation criteria and if criteria is not met, initiate deviations according to applicable compliance procedures, perform impact assessment and implement corrective actions. Address daily quality concerns and questions related to instrument/equipment issues like Instrument calibration, standardization procedures,

Instrument breakdown, and Instrument consumables replacement and follow up on corrective actions. Develop risk assessment and mitigation plans through FMEA's, and other risk assessment tools for laboratory systems. Review analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards. Manage

metrics like Project Schedules, Quality metrics, risk management using tools like Gantt chart, Pareto charts, risk matrix as required and temperature excursion charts for applicable

laboratory Instruments on a regular basis. Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Develop knowledge of and understand

regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.

Requirements:

• Bachelor's (or foreign equivalent) degree in Chemical Engineering, Biomedical Engineering, or related field.
• Two years of work experience in the Job Offered, or as a Validation Engineer, Qualification Engineer, or related.
• Some work experience required with: 1) Calibration, maintenance and troubleshooting of analytical instruments (TOC Analyzers, Plate readers, Density meters); 2) Computerized Instrument System Validation (21CFR Part11 regulations); 3) Quality risk assessment (FMEA, Risk Matrix); 4) Qualification of GMP storage units (Kaye validators, Wireless monitoring software); and 5) Qualification of analytical instruments (TOC Analyzers, Karl Fisher Titrators, UV-Vis spectrometers, Absorbance plate readers, Autoclaves).

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.

Read more about Xellia Pharmaceuticals here

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