QC Microbiologist & EM Technician (m/f/d)

SThree; Wiesbaden; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

SThree in Wiesbaden is seeking a microbiologist for a full-time role focused on microbiological testing and environmental monitoring. Ideal candidates will hold a Bachelor's or Master's degree in relevant life sciences and have 3-5 years of experience in a GMP-regulated lab. Proficiency in both German and English is essential.

This is an 18-month contract with employee leasing arrangements. Interested candidates should submit their CV, start date availability, and salary expectations.

Qualifikationen

• 3-5 years of hands-on experience in a GMP-regulated microbiology laboratory.
• Proficiency in microbiological testing techniques and aseptic practices.
• Knowledge of cleanroom operations and cGMP regulatory requirements.

Aufgaben

• Perform routine microbiological testing on raw materials and products.
• Execute environmental monitoring activities in cleanroom areas.
• Support qualification and validation activities.

Kenntnisse

Microbiological testing techniques

Attention to detail

Problem-solving skills

Analytical skills

Aseptic practices

Environmental monitoring protocols

German proficiency

English proficiency

Ausbildung

Bachelor's or Master's degree in Microbiology, Biology, Biochemistry, or related life sciences

Tools

Laboratory information management systems (LIMS)

Quality systems such as TrackWise

Jobbeschreibung

Project Details

• Start: asap
• Duration: 18 months
• Workload: Full‑time (on‑site)
• Locations: Wiesbaden, followed by Alzey
• Contract type: Employee leasing (Arbeitnehmerüberlassung)

Key Responsibilities

• Perform routine microbiological testing including sterility, endotoxin, bioburden, biological indicators, microbial identification, and method suitability testing on raw materials, in‑process samples, finished products, water, and gases.
• Execute environmental monitoring activities including viable and non‑viable air sampling, surface monitoring, personnel monitoring, water sampling, and compressed gas testing in classified cleanroom areas.
• Support qualification and validation activities including Environmental Monitoring Performance Qualification (EMPQ), Pre‑Approval Readiness (PAR) cycles, Clean Utilities PQ, and CIP/SIP validation protocols.
• Operate, maintain, and calibrate laboratory equipment and EM instruments including air samplers, particle counters, incubators, autoclaves, and analytical instruments in compliance with maintenance schedules.
• Prepare and maintain microbial stock cultures, growth media, reagents, and consumables; manage laboratory inventory and perform material qualifications.
• Execute accurate documentation in LIMS and electronic systems; ensure data integrity in compliance with ALCOA+ principles and good documentation practices (GDP).
• Identify, investigate, and document deviations, out‑of‑specification (OOS) results, and environmental excursions; participate in root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
• Create, review, and revise standard operating procedures (SOPs), protocols, work instructions, trend reports, and technical documentation to support site operations and regulatory compliance.
• Coordinate external laboratory testing including sample submission, result review, and oversight of contract laboratory activities to ensure quality and compliance.

Required Profile

• Bachelor's or Master's degree in Microbiology, Biology, Biochemistry, or related life sciences discipline.
• 3-5 years of hands‑on experience in a GMP‑regulated microbiology laboratory within the pharmaceutical or biotechnology industry.
• Proficiency in microbiological testing techniques, aseptic practices, and environmental monitoring protocols.
• Familiarity with laboratory information management systems (LIMS) such as MODA, SmartLab, and quality systems such as TrackWise.
• Knowledge of cleanroom operations, contamination control strategies, and cGMP regulatory requirements (FDA, EMA, EU GMP Annex 1).
• Understanding of ALCOA+ data integrity principles and good documentation practices.
• Proficiency in both German and English (written and oral communication).
• Strong attention to detail with excellent problem‑solving and analytical skills.
• Ability to work independently and collaboratively in cross‑functional teams.

If you are interested, please send me your current CV, including your earliest possible start date and desired gross annual salary, as well as your references. I will get back to you after reviewing your application.

If you are not interested or currently unavailable but know someone who might be a good fit for this position, please let us know.

I look forward to your response and thank you in advance.

Kind regards,
Mariam Gareginyan
Associate Principal Candidate Consultant
E‑Mail: m.gareginyan(@)sthree.com

SThree_Germany is acting as an Employment Business in relation to this vacancy.