V
Microbiology Supervisor
Galway Metropolitan Area (Hybrid) · Contrato
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- Experiencia
- Cualquier
- Salario
- —
- Vacantes
- 1
- Al corriente
- Hace 10 horas
- Modo de trabajo
- Híbrido
- Educación
- Degree in Microbiology or related discipline
- Reanudar
- Se requiere solicitud
Descripción del trabajo
Role Overview
Join a leading sterile manufacturing site as a Microbiology Team Lead based in Galway, Ireland, with flexible remote working options on a full-time 12-month contract. This role emphasizes leading microbiology investigations, supporting equipment qualification and automation projects, and managing microbiology professionals within a GMP environment focused on sterile pharmaceuticals and biologics.
Key Responsibilities
- Oversee microbiology investigations from start to resolution, ensuring thorough root cause analysis and impact evaluation.
- Coordinate laboratory projects and automation efforts effectively.
- Manage equipment qualification processes including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
- Collaborate with vendors, Quality Assurance, Technical Services, and Manufacturing teams.
- Organize Tier 1 operational meetings and monitor the progress of investigations and projects.
- Support compliance with Annex 1 regulations.
- Effectively prioritize workload across multiple GMP laboratory functions.
- Provide mentorship and support to microbiology technicians.
Candidate Profile
- A degree in Microbiology, Pharmaceutical Sciences, or a related scientific discipline.
- Demonstrated experience in microbiology within pharmaceutical, biopharmaceutical, or biologics manufacturing settings.
- Proven expertise in leading microbiology investigations.
- Comprehensive understanding of sterile manufacturing processes and environmental monitoring programs.
- Experience with media fill simulations and knowledge of Annex 1 requirements.
- Familiarity with GMP equipment qualification activities and documentation standards.
- Strong communication and stakeholder management capabilities.
- Skilled at balancing operational priorities with continuous improvement initiatives.
Habilidades
Análisis de la causa raíz
Coordinación de proyectos
Comunicación con las partes interesadas
Liderazgo de equipo
Cumplimiento de las Buenas Prácticas de Fabricación (BPF)
Environmental Monitoring
Microbiology
Annex 1 Compliance
Sterile manufacturing processes
Microbiology investigations
Equipment qualification (IQ/OQ/PQ)
Media fill simulations