QC Microbiologist (Germany)

Oxford Global Resources; Madrid; On-site; EUR 61,000 - 73,000; Full time

Job summary

Oxford Global Resources seeks a QC Microbiologist to establish a new department in a 18-month project. You will conduct microbiological testing across the plant, including environmental monitoring of cleanrooms, water, gases, and surfaces, while ensuring cGMP compliance and data integrity.

The role involves qualification/validation support (EMPQ, PQ for clean utilities) and collaboration with external labs. Fluency in English is required, and night/weekend OT may apply during critical phases.

Qualifications

• Bachelor’s or Master’s degree in microbiology, biology, biochemistry or related life sciences.
• 3–5 years hands-on GMP microbiology lab experience in pharma/biotech.
• Proficiency in microbiological testing methods and environmental monitoring protocols.

Responsibilities

• Perform routine microbiological testing including sterility, endotoxin, bioburden, and microbial ID.
• Carry out environmental monitoring in cleanrooms and sample air, surfaces, water and gases.
• Support qualification and validation activities (EMPQ, PQ for clean utilities, CIP/SIP).
• Operate, calibrate and maintain lab equipment and EM instruments.
• Prepare and manage cultures, media, reagents, and consumables; manage inventory.

Skills

GMP microbiology

Environmental monitoring

LIMS experience

Cleanroom operations

Documentation & GDP

English fluency

Education

Bachelor’s or Master’s degree in microbiology / life sciences

Tools

MODA

SmartLab

TrackWise

Job description

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 Global 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