Overview
Project Microbiology Specialist – 12 Month Contract – Pharmaceuticals.
Our client is undergoing major growth, supported by substantial investment aimed at increasing its overall manufacturing capacity in the medical device sector.
Recent upgrades include the development of new, advanced automation systems and additional infrastructure enhancements designed to meet growing global healthcare demands.
The site requires the role of a Project Microbiology Specialist to join their project based in Cork, Ireland.
Responsibilities
Collaborate with the Project Microbiologist to ensure microbiology considerations are integrated into project planning, design, installation, commissioning and qualification activities.
Provide microbiological input to engineering design reviews, URS development, and equipment selection to ensure compliance with CCS principles.
Participate in project risk assessments (e.g., microbiological risk, contamination control assessments) and contribute to mitigation strategies.
Participate in discrepancy resolution and validation failure investigations.
Qualifications
Experience in pharmaceutical, biologics, or biotechnology manufacturing or QC microbiology.
Strong understanding of GMP regulations and regulatory expectations for contamination control and facility qualification.
Experience supporting or leading microbiology activities within facility expansions, capital projects or tech transfers is desirable.
Working knowledge of environmental monitoring programs, Annex 1 compliant manufacturing, cleanroom classification, and microbial contamination risks.
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