Site Microbiologist (m/f/d)

SThree; Wiesbaden; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

SThree Germany is seeking an experienced Site Microbiologist (m/f/d) for a pharma project in Wiesbaden, with activities shifting to Alzey. Start asap, contract type: Arbeitnehmerüberlassung with permanent employment option.

The role covers method validation, water systems, environmental monitoring, and CAPA-driven improvements across GMP-compliant operations. The candidate will lead microbiology investigations, support regulatory audits, and mentor laboratory staff.

Qualifikationen

• Strong knowledge of QC Microbiology, Environmental Monitoring, Water Systems and GMP requirements.
• Excellent analytical, problem-solving and communication skills.
• Fluent English in writing and speaking.

Aufgaben

• Oversee microbiology method validations and transfers per GMP, USP, Ph. Eur. and internal standards.
• Support rapid microbial method development and instrument qualification/validation lifecycles.
• Serve as SME for water systems (WFI, Purified Water, Clean Steam) and sampling plans.
• Lead environmental monitoring programs across manufacturing and lab areas (Grade A–D).
• Support regulatory audits and inspections with technical microbiology input.
• Contribute to investigations (OOS/OOT), CAPAs and root-cause analysis.
• Support QC Microbiology in cross-functional projects and resource planning.
• Review and approve microbiological data from raw materials to finished products.

Kenntnisse

QC Microbiology

Environmental Monitoring

Water Systems

Sterility Assurance

GMP knowledge

Ausbildung

Degree in Microbiology or life sciences

Jobbeschreibung

for a pharmaceutical project, I am currently looking for an experienced Site Microbiologist (m/f/d).

• Start: asap
• Duration: 18 months
• Locations: Wiesbaden, followed by Alzey
• Contract type: Employee leasing (Arbeitnehmerüberlassung) with the option of permanent employment

Key Responsibilities

Method Validation & Method Transfer

• Provide technical oversight of microbiological method validations and method transfers in accordance with GMP, USP, Ph. Eur., and internal quality standards.
• Apply expertise in compendial microbiological testing, including sterility, bioburden, and endotoxin testing.
• Support the introduction and development of rapid microbial methods.
• Contribute to the validation lifecycle of analytical instruments from user requirements through qualification and release.

Water Systems

• Act as the microbiological SME for water systems, including WFI, Purified Water, Clean Steam, and source water systems.
• Support the design and implementation of water sampling plans during qualification and routine monitoring activities.
• Interpret microbiological and endotoxin data and drive continuous improvement initiatives based on findings.

Environmental Monitoring & Contamination Control

• Serve as the microbiological SME for environmental monitoring programs, including viable and non-viable monitoring across Grade A-D manufacturing and laboratory areas.
• Support the implementation and improvement of environmental monitoring strategies in line with regulatory requirements.
• Contribute to the development and maintenance of contamination control strategies (CCS).
• Provide microbiological expertise for equipment and processes such as autoclaves, isolators, depyrogenation tunnels, and CIP/SIP systems.
• Evaluate and interpret microbiological data from biological indicators, endotoxin indicators, rinse samples, and swab samples.
• Support validation and ongoing monitoring activities for sterilization and cleaning processes.

Audits & Regulatory Inspections

• Act as a microbiology SME during internal, customer, and regulatory audits.
• Present technical information directly to inspectors and auditors.
• Support audit preparation, responses, and follow-up activities.

Investigations & CAPAs

• Lead and support GMP investigations, including OOS, OOT, deviations, and atypical results.
• Utilize structured root cause analysis tools such as 5-Why and Fishbone (Ishikawa) methodologies.
• Develop scientifically sound conclusions and implement effective corrective and preventive actions (CAPAs).

Project Support & Laboratory Operations

• Represent QC Microbiology on cross-functional projects.
• Contribute to workload forecasting, resource planning, and laboratory strategy.
• Support continuous improvement initiatives across microbiological processes and systems.

Data Review & Quality Support

• Review, interpret, and approve microbiological data related to raw materials, in-process samples, and finished products.
• Contribute to Annual Product Reviews, process validation activities, and quality improvement initiatives.
• Provide technical training and mentorship to laboratory personnel.
• Support the development of microbiological expertise across the organization.
• Contribute to the implementation of quality and compliance standards.

Qualifications

• Degree in Microbiology, Biology, Biotechnology, Pharmacy, or a related life science discipline.
• Significant experience within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Strong knowledge of QC Microbiology, Environmental Monitoring, Water Systems, Sterility Assurance, and GMP requirements.
• Experience supporting regulatory inspections and audits is highly desirable.
• Excellent analytical, problem-solving, and communication skills.
• Fluent English language skills, both written and spoken.

Desired Skills and Experience

Microbiologist, QC Microbiology, Environmental Monitoring, Water Systems, Sterility Assurance, GMP, CAPA

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