GMP Microbiology Analyst II – Lab Testing & Validation

Complete Laboratory Solutions; Galway; On-site; EUR 32,000 - 52,000; Full time

Job summary

Complete Laboratory Solutions (CLS) is seeking a dedicated microbiology professional during a period of growth. The role involves performing microbiological testing (PET, Endotoxin, Pharmaceutical Product Testing) and supporting new client testing requirements, with emphasis on cGMP and GDP compliance.

You will contribute to method transfers and validations, maintain accurate documentation in LIMS, manage stocks, and support Lean Laboratory initiatives within the microbiology lab.

Qualifications

• 3rd level qualification in microbiology or a science related discipline.
• 1-2 years’ experience. Endotoxin experience desired.
• Strong communication skills, both verbal and written.
• Effective team player with excellent organizational and documentation skills.
• Ability to work accurately, efficiently, and compliantly in a dynamic, progressive environment.
• Strong knowledge of microbiological aspects of GMP for pharmaceutical and medical devices
• Good knowledge of GMP Standards and FDA requirements

Responsibilities

• Work as directed by Microbiology Lab Supervisor according to safety policies and cGMP.
• Perform microbiological testing including PET, Endotoxin, Pharmaceutical Product Testing, and other assigned tasks.
• Support the setup of new client testing requirements and specifications; contribute to the generation of new test methods and method transfers.
• Participate in validation activities, including Biological Indicator (BI) studies and cleaning verification.
• Adherence to GMP and GDP.
• Data entry of test results into LIMS system.
• Record results promptly, ensuring accuracy and compliance with procedures.
• Conduct and assist with investigations of out-of-specification (OOS) results, ensuring adherence to site procedures.
• Complete all testing documentation and LIMS entries, ensuring Right First Time (RFT) KPIs are met.
• Manage stock control and maintain adequate supplies within the Microbiology Laboratory.
• Generate, update, and maintain laboratory documentation as required.
• Contribute to the Lean Laboratory program within the Microbiology Laboratory.

Skills

Strong communication

Team player

Organisational skills

Documentation skills

GMP knowledge

Education

3rd level qualification in microbiology or science related discipline

Job description

Complete Laboratory Solutions (CLS) is seeking a dedicated microbiology professional during a period of growth. The role involves performing microbiological testing (PET, Endotoxin, Pharmaceutical Product Testing) and supporting new client testing requirements, with emphasis on cGMP and GDP compliance.

You will contribute to method transfers and validations, maintain accurate documentation in LIMS, manage stocks, and support Lean Laboratory initiatives within the microbiology lab.