Dear sir or madam, for a pharmaceutical project, I am currently 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 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 (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. 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. We reward every successful referral with a €250 Amazon voucher! 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.