Site Microbiologist (m/f/d)

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.