Microbiology Scientist – GMP & Aseptic Processes (3833)
Posted 24 days ago · 0 applicants
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The role in plain words
- B.Sc. or higher in Microbiology, Life Sciences, Biotechnology, or related field
- Previous experience in the biopharmaceutical industry
- Strong background in aseptic manufacturing environments and GMP
- Experience leading microbiological investigations and quality documentation
- Familiarity with relevant regulations and guidelines (EU, FDA, PDA)
Extracted from the job description · kept up to date automatically
Who this suits
Full job description
Original listing · kept for referenceWe’re looking for a Qualified Industrial Microbiologist to join a leading biopharmaceutical company and take a key role in supporting aseptic manufacturing processes for biological drug products.
This role combines scientific expertise, quality investigation leadership, and cross-functional collaboration in a highly regulated GMP environment.
Key responsibilities include:
• Leading investigations of microbiological deviations, OOS/OOT events, and contamination-related issues
• Performing Root Cause Analysis and defining CAPAs
• Writing investigation reports, risk assessments, and quality documentation
• Monitoring and trending microbiological data (Bioburden, Endotoxin, etc.)
• Supporting and leading projects focused on contamination control and aseptic process improvement
• Providing microbiological expertise in support of regulatory inspections and compliance activities (FDA / EU GMP)
Requirements:
• B.Sc. or higher in Microbiology, Life Sciences, Biotechnology, or related field
• Previous experience in the biopharmaceutical industry
• Strong background in aseptic manufacturing environments and GMP
• Experience leading microbiological investigations and quality documentation
• Familiarity with relevant regulations and guidelines (EU, FDA, PDA)
• High-level English communication skills
• Independent, analytical, and proactive mindset
A great opportunity to join an advanced pharma environment with meaningful scientific and operational impact.
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- B.Sc. or higher in Microbiology, Life Sciences, Biotechnology, or related field, Previous experience in the biopharmaceutical industry, Strong background in aseptic manufacturing environments and GMP, Experience leading microbiological investigations and quality documentation, Familiarity with relevant regulations and guidelines (EU, FDA, PDA)