On behalf of one of our clients in the pharmaceutical industry, we are looking for a Responsible Scientist QC Microbiology (m/f/d). In this expert role, you bring in-depth, hands-on GMP microbiology knowledge to the QC microbiology laboratory, sterile manufacturing areas and utility systems, and serve as the central technical point of contact for topics ranging from method validation to audit support.
Job Description
As a Subject Matter Expert, you are responsible for key microbiology topics such as method transfers and validations, water systems, environmental monitoring in Grade A to D cleanrooms, and sterilization and cleaning validation. You lead GMP investigations into deviations and OOS/OOT results, derive sound CAPAs, and represent microbiology in direct exchange with regulatory authorities during inspections. In addition, you review and release analytical data, plan the QC microbiology workload, and share your expertise with analysts through structured training.
Responsibilities
- Technical oversight of method transfers and validations (sterility, bioburden, endotoxin) in line with GMP, USP/Ph. Eur. and global lab quality standards, including further development of rapid microbial methods
- Microbiology SME for water systems (WFI, PW, clean steam, source water), including sampling plans, result interpretation and process improvement
- SME for environmental monitoring (viable/non-viable) in Grade A to D areas, aligned with the overall contamination control strategy
- Microbiological support of sterilization, depyrogenation and cleaning validations (autoclaves, isolators, dry heat tunnels, CIP/SIP)
- Front-room SME during regulatory inspections and audits, including audit tours and responses
- Leading GMP investigations (OOS/OOT, deviations) using root cause methodologies such as 5-Why and Ishikawa, and defining CAPAs
- Technical review and release of raw material, in-process and finished product data, and contribution to annual product reviews and process validations
- Representing QC microbiology in projects, forecasting workload, and training and mentoring analysts
Requirements
- Master's or Bachelor's degree in a scientific or engineering discipline
- 7-10 years of relevant experience in GMP microbiology laboratories, sterile manufacturing areas and utility systems
- Experience across the full lifecycle of microbiological test methods (development, verification, transfer, validation, remediation)
- Deep knowledge of regulatory requirements, in particular GMP, USP, Ph. Eur. and EU GMP Annex 1
- Strong problem-solving skills, ideally with formal training in root cause analysis
- Confident interaction with business partners and auditors, combined with strong communication skills
- Strong focus on continuous improvement
- Excellent English skills; German is an advantage
Working Conditions
- Contract: Fixed-term for 18 months; employment via Oxford Global Resources
- Salary: Between €6,000 and €7,000 per month
- Working hours: 40 hours per week
Only applicants who hold the citizenship of an EU member state or a valid permanent residence permit for Germany (Niederlassungserlaubnis) are legally permitted to accept this position (Section 40 (1) No. 2 of the German Residence Act, AufenthG)
Job ID: 27669
Phone number: +49 211 88230168
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Senior Scientist QC Microbiology (m/f/d) in Mainz Arbeitgeber: Oxford Global Resources
Unser Unternehmen bietet eine dynamische und unterstützende Arbeitsumgebung, in der Teamarbeit und kontinuierliche Weiterbildung großgeschrieben werden. Als Mechaniker in der pharmazeutischen Produktion profitieren Sie von attraktiven Vergütungen, flexiblen Schichtmodellen und 30 Urlaubstagen pro Jahr, während Sie in einem modernen Standort in Singen arbeiten, der sich durch innovative Technologien und hohe Qualitätsstandards auszeichnet. Wir legen Wert auf Sicherheit und Qualität, was Ihnen die Möglichkeit gibt, Ihre Fähigkeiten in einem bedeutenden und wachsenden Sektor weiterzuentwickeln.
