Senior Microbiologist

Eastmen Human Resources B.V.; Deutschland; Vor Ort; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Senior Microbiologist to oversee microbiological quality control at their facility. This role involves ensuring compliance with cGMP regulations, leading a team of microbiologists, and developing testing methodologies. The ideal candidate will have extensive experience in microbiology, a strong grasp of regulatory standards, and a commitment to fostering a culture of safety and continuous improvement. Join a forward-thinking company that values diversity and inclusivity while making a significant impact on quality assurance in the microbiology field.

Qualifikationen

• Mindful of cGMP regulations and microbiological best practices.
• 3+ years of experience in a GMP microbiology lab.

Aufgaben

• Lead microbiologists and ensure compliance with quality control systems.
• Develop and validate microbiological testing methods.

Kenntnisse

GMP Microbiology

Microbiological Testing Methods

Regulatory Compliance (USP, EU, ISO)

Environmental Monitoring

Team Leadership

Tools

Microbiological Equipment

Jobbeschreibung

The Senior Microbiologist is responsible for ensuring that microbiological quality control systems and activities, including training and environmental monitoring, comply with cGMP regulations and guidelines at the Dechra Skipton facility.

Main Responsibilities

1. Stay updated on developments in the microbiology field through training, literature review, and documentation.
2. Provide technical expertise to update methodologies and adopt best practices.
3. Ensure adherence to microbiological best practices across all site projects, especially those involving new equipment, technology, or processes.
4. Promote a culture of safety and continuous improvement in quality.
5. Support company-wide continuous improvement initiatives.
6. Collaborate cross-functionally to manage departmental processes, meet product delivery goals, and establish plans.
7. Lead, coach, and motivate microbiologists; conduct performance reviews and development interviews.
8. Participate in operational and quality meetings.
9. Investigate out-of-specification results, environmental excursions, and deviations per company procedures.
10. Develop and validate microbiological testing methods for raw materials and finished products.
11. Assist in writing validation protocols, project reports, SOPs, and test methods.
12. Provide strategic input to ensure good microbiological practices in manufacturing areas.
13. Offer microbiological expertise during planning and implementation of new procedures, products, and process improvements.
14. Assess microbiological performance of utilities, HVAC, and environmental monitoring for batch release support.
15. Lead investigations into microbiology-related excursions and support related groups during investigations.
16. Manage special projects like disinfectant efficacy studies.
17. Approve monthly microbiology and environmental trend reports.
18. Coordinate with QC microbiologists on microbiological trending and corrective actions.
19. Deliver technical and underpinning knowledge training to manufacturing and analytical teams.
20. Represent the company during regulatory inspections and prepare/respond to regulatory documentation.
21. Ensure safety and compliance with all relevant legislation and company policies.
22. Sample facilities and utilities using various microbiological methods.
23. Execute microbiological tests including water testing, bioburden, and environmental monitoring.
24. Perform dispersion testing, process and cleaning validation studies, and stability studies.
25. Coordinate sample dispatch to external labs and manage third-party results.
26. Maintain and calibrate microbiological equipment, manage inventory, and perform routine maintenance.

Ideal Candidate

Dechra values diversity and inclusivity. We are particularly interested in candidates who have:

• Strong knowledge of USP, EU, and ISO regulations.
• At least 3 years of relevant GMP microbiology laboratory experience.
• Proficiency in microbiological testing methods such as LAL, membrane filtration, bioburden, environmental monitoring, dispersion, microscopy, Gram staining, and incubation.
• Knowledge of laboratory equipment used in microbiology testing.