- Company Name
- Skills Alliance Enterprise
- Job Title
- Microbiologist
- Job Description
-
**Job title**
Microbiologist – 12 Month Maternity Leave Replacement
**Role Summary**
Provide advanced microbiological support to a GMP‑outlined biopharmaceutical manufacturing environment. Core duties include enumeration, identification, and sterility testing, as well as process qualification, quality investigations, documentation, and LEAN implementation.
**Expectations**
- Minimum 5 years of laboratory microbiology experience (or 2 years with a BSc/MSc).
- Proven ability to work independently, meet strict timelines, and stay compliant with GMP and regulatory requirements.
**Key Responsibilities**
1. Maintain laboratory and equipment to GMP standards: stock control, waste management, cleaning, calibration, and service.
2. Execute routine microbiological tests: sterility, endotoxin, bioburden, mycoplasma, growth‑promotion/fertility, enumeration, microscopy, and identification.
3. Perform equipment, method, and process qualification, validation, and verification.
4. Lead quality‐related activities: investigations, deviations, CAPAs, change controls.
5. Author, review, and archive GMP documentation (SOPs, logs, investigations, CAPAs, change controls).
6. Identify and implement LEAN processes within the microbiology function.
7. Train microbiology staff and cross‑departmental teams on SOPs, techniques, and GMP practices.
**Required Skills**
- Advanced knowledge of aseptic processing and sterile manufacturing.
- Expertise in ATMP/Vector sampling, CMC, and regulatory compliance.
- Deep understanding of pharmacopeial monographs, assay principles, and regulatory guidance.
- Proficiency in GMP instrument qualification (URS/DQ/IOPQ) and documentation (ALCOA, SOPs, logbooks).
- Skilled in data integrity, environmental monitoring data analysis, and report generation.
- Advanced proficiency in MS Word, Excel, PowerPoint, DOE and other relevant software.
**Required Education & Certifications**
- BSc/MSc in Life Sciences, Microbiology, or related field (preferred but not mandatory with ≥5 years experience).
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Stevenage, United kingdom
On site
Mid level
29-01-2026