Microbiology Specialist

About the Role

Valtera Group Ltd is searching for two seasoned Microbiology Specialists to join their sterile production microbiology team in Galway. This full-time contract position, lasting 12 months, emphasizes tasks beyond routine testing, focusing instead on deeper investigative and analytical duties within a GMP-compliant environment.

Key Responsibilities

• Lead and contribute to microbiological investigations and deviation evaluations.
• Conduct thorough reviews of microbiology documentation and GMP records.
• Analyze microbiological data to determine product quality impacts.
• Manage root cause analyses and ensure completion of CAPA initiatives.
• Assist with media fill procedures and related documentation compliance.
• Take part in Gemba investigations and offer support for manufacturing processes.
• Provide expert guidance on environmental monitoring programs from a microbiology perspective.
• Support ongoing improvement projects and other initiatives.

Required Qualifications and Experience

• Relevant degree in Microbiology, Pharmaceutical Sciences, or similar discipline.
• Minimum of five years' microbiology experience within pharmaceutical, biologics, or biopharmaceutical sectors.
• Experience operating in sterile manufacturing settings.
• Demonstrated expertise leading microbiological investigations, managing deviations, and driving CAPA to resolution.
• In-depth understanding of contamination control and media fill methodology.
• Proficiency in reviewing GMP documentation and laboratory records.
• Knowledge of MODA, LIMS, or automated microbiology systems is a plus.
• Strong analytical thinking and problem-solving capabilities.