QC Microbiologist (m/f/d)

Job Overview

For a pharmaceutical project, we are looking for an experienced QC Microbiologist & Environmental Monitoring (EM) Technician (m/f/d) to support the setup and operational phase of a manufacturing site. The objective of this role is to help establish a robust Quality Control Microbiology function, ensuring microbiological quality, GMP compliance, and inspection readiness during site start‑up and ongoing operations.

Project Details

• Start: ASAP
• Duration: 18 months
• 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 (EM) 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.

E‑Mail: m.gareginyan(@)sthree.com