QC Microbiology Scientist | GMP, Validation & Tech Lead

Biopharma Careers; Limerick; On-site; EUR 37,000 - 75,000; Full time

Job summary

Regeneron in Raheen, Limerick is seeking a QC Microbiology Associate Scientist/Scientist to join our QC Tech Resources team. You will validate methods and equipment related to sterility, bioburden, endotoxin testing, and microbial identifications.

You will write technical documentation, oversee contract laboratory testing, coach junior staff, and support regulatory inspections to ensure GMP compliance and robust microbial investigations.

Qualifications

• BS/BA in Microbiology or related field with 2+ years of validated experience.

Responsibilities

• Validating methods and equipment related to sterility, bioburden, endotoxin testing, and microbial identifications.
• Writing technical documentation, including position papers, validation reports, and microbiological investigations.
• Culturing organisms, conducting research, and characterizing them for use in investigations and cleaning development.
• Reviewing new test procedures and assays for accuracy and compliance.
• Evaluating and acquiring new methodologies, techniques, and equipment as needed.
• Overseeing contract laboratory testing to ensure quality and compliance.
• Setting product specifications and alert/action levels for microbiological standards.
• Leading technical troubleshooting and problem investigations.
• Reviewing assay, process, and equipment validation reports, as well as other technical documents for correctness and regulatory compliance.
• Coaching junior team members on good microbiology lab practices and modern aseptic techniques.
• Supporting and participating in regulatory inspections to ensure compliance.
• Demonstrating investigational skills and working knowledge of microbiology assay development and validation.

Job description

Regeneron in Raheen, Limerick is seeking a QC Microbiology Associate Scientist/Scientist to join our QC Tech Resources team. You will validate methods and equipment related to sterility, bioburden, endotoxin testing, and microbial identifications.

You will write technical documentation, oversee contract laboratory testing, coach junior staff, and support regulatory inspections to ensure GMP compliance and robust microbial investigations.