Microbiology Technician II

Company Overview

Viatris is an international healthcare organization blending the strengths of generics and branded medicines to comprehensively address global healthcare needs. They provide accessible quality medicines to nearly one billion patients worldwide each year, impacting all life stages and a wide range of health conditions. The company prioritizes creating a collaborative and inclusive workplace that encourages employees to realize their potential while making a positive difference globally.

Role Summary

The Microbiology Laboratory Technician II will conduct routine microbiological tests on raw materials, water samples, in-process and finished pharmaceutical products, and environmental monitoring in classified cleanroom areas and compressed gases. The role involves proper GMP documentation, data recording, report preparation, laboratory data review, and supporting investigations.

Key Responsibilities

• Conduct bioburden testing of raw materials, waters, in-process and finished product samples using membrane filtration or direct methods.
• Perform endotoxin assessments with Gel Clot or kinetic assays on raw materials, components, and finished products.
• Carry out sterility testing on finished product samples and components.
• Monitor environmental conditions of classified areas and compressed gases.
• Identify microorganisms to species level.
• Ensure growth promotion and sterility testing of microbiological media.
• Support process qualification and stability studies.
• Validate test methods related to bioburden, endotoxin, and bacteriostasis/fungistasis, assisting in report preparation.
• Analyze environmental and personnel monitoring plates from cleanroom areas.
• Evaluate microbiological test results, including bioburden and sterility testing outcomes.
• Identify trends in microbiological and environmental monitoring data.
• Inspect media fills for compliance.
• Manage stock levels for media plates and consumables, ordering as necessary.
• Train colleagues as required, maintaining proper documentation of training activities.
• Perform container closure integrity testing.
• Maintain microbiology laboratory calibration schedules.
• Prepare laboratory investigation reports as assigned.
• Compile environmental monitoring trend reports for Grade C and Grade D areas and Water for Injection (WFI) summaries.
• Review raw data and laboratory logbooks thoroughly.

Required Qualifications & Experience

• Bachelor's degree or equivalent in a science discipline, preferably Microbiology.
• Two to four years of experience in microbiology within a pharmaceutical setting.
• Proficient in sterility, bioburden, and endotoxin testing.
• Knowledge of USP and European Pharmacopoeia microbiological standards.
• Capability to write thorough investigation reports using risk analysis methodologies.
• Experience working in FDA and HPRA regulated environments.
• Familiarity with environmental monitoring practices in sterile manufacturing.
• Strong mathematical skills at the tertiary education level.
• Exceptional attention to detail and accuracy.
• Competent with Microsoft Word and Excel.

Diversity & Inclusion Statement

Viatris is committed to fostering a diverse and inclusive workplace. Candidates who do not meet every qualification but show potential are encouraged to apply. The company values diversity as a core strength that helps redefine healthcare.

Corporate Responsibility

Viatris integrates sustainability and corporate social responsibility into its mission, working to empower healthier lives worldwide while supporting communities and stakeholders responsibly.

Employer Note

The company offers competitive salary packages, benefits, and an inclusive culture to help employees use their skills for impactful work. Viatris is an Equal Opportunity Employer.