23 oct
|
Oxford Global Resources
|
Madrid
23 oct
Oxford Global Resources
Madrid
Germany 18 months project at one of our clients, one of the largest pharmaceutical or biotechnology companies in the world, is currently looking for 3 Microbiologists (m/f/d) to build up a new QC Microbiology department. Job Description As a QC Microbiologist (m/f/d), you will be responsible for carrying out microbiological testing and environmental monitoring activities across the entire plant, ensuring that all work complies with cGMP standards and applicable regulatory requirements. The role includes routine testing of raw materials, in-process samples and finished products, water and gases, as well as cleanroom monitoring, including sampling of viable and non-viable particles in the air, surface and personnel monitoring, and testing of compressed gases. This is particularly relevant so that all processes for the new department can be established. Beyond routine activities, the position makes an active contribution to qualification and validation activities, including performance qualification of the environmental monitoring program and protocols for clean utilities.
Responsibilities Perform routine microbiological testing, including sterility testing, endotoxin testing, bioburden testing, microbial identification and method suitability testing for a wide variety of sample types
Carry out environmental monitoring in classified cleanroom areas, including sampling of viable and non-viable particles in the air, on surfaces, on personnel, in water and in compressed gases
Support qualification and validation activities such as EMPQ, pre-approval readiness cycles, PQ for clean utilities and CIP/SIP validation
Operate, calibrate and maintain laboratory equipment and EM instruments in accordance with scheduled maintenance programs
Prepare and manage microbial cultures, culture media, reagents and consumables, including inventory control and material qualification
Accurately record all activities in LIMS and electronic systems, ensuring full compliance with ALCOA+ data integrity and GDP requirements
Identify, investigate and document deviations, OOS results and excursions; support root cause analysis and the implementation of CAPAs
Prepare and review SOPs, protocols, work instructions and technical reports; coordinate external laboratory testing and oversee contract laboratories
Profile Bachelor’s or Master’s degree in microbiology, biology, biochemistry or a related life sciences field
3-5 years of hands-on experience in a GMP-regulated microbiology laboratory in the pharmaceutical or biotech industry
Proficiency in microbiological testing methods, aseptic techniques and environmental monitoring protocols
Experience with LIMS platforms (e.g., MODA, SmartLab) and quality management systems (e.g., TrackWise)
Solid knowledge of cleanroom operations, contamination control strategies and cGMP frameworks, including FDA, EMA and EU GMP Annex 1
Familiarity with ALCOA+ principles and good documentation practices
Fluent English, spoken and written
Willingness to work shifts, weekends or overtime during critical operational phases (night, Sunday and overtime work is compensated separately)
Working Conditions Contract: Fixed-term for 18 months; employment via Oxford Integral Resources
Salary: Between €5,500 and €6,500 per month, depending on level of experience
Working hours: 40 hours per week with flexible working hours, and willingness to work shifts, weekends or overtime during critical operational phases
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📌 QC Microbiologist (Germany) (Madrid)
🏢 Oxford Global Resources
📍 Madrid