QC Microbiologist (m/f/d) - #999195

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.