QC Microbiology Scientist – GMP Lab & Validation

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 37,000 - 75,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc in Raheen, Limerick is seeking a QC Microbiology Associate Scientist / Scientist to join the QC Tech Resources team, supporting sterility, bioburden and endotoxin testing and microbial identifications.

You will validate methods and equipment, write technical documentation, culture organisms, review procedures, and aid in regulatory inspections, with responsibilities spanning investigations and QA compliance.

Qualifications

• Strong background in pharmaceutical microbiology.
• GMP working experience in QC labs.
• Aseptic techniques experience.
• Excellent written and oral communication skills.

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.

Skills

Independent work

Team collaboration

GMP QC experience

Aseptic techniques

Education

BS/BA in Microbiology or related field

Job description

Regeneron Pharmaceuticals, Inc in Raheen, Limerick is seeking a QC Microbiology Associate Scientist / Scientist to join the QC Tech Resources team, supporting sterility, bioburden and endotoxin testing and microbial identifications.

You will validate methods and equipment, write technical documentation, culture organisms, review procedures, and aid in regulatory inspections, with responsibilities spanning investigations and QA compliance.