8 дней назад
Plant Microbiologist (Biopharmaceutical Manufacturing)
68 600 - 119 600€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Plant Microbiologist (Biopharmaceutical Manufacturing): Supporting contamination control and microbiological risk management in GMP-regulated sterile and aseptic manufacturing with an accent on environmental monitoring, investigations, and operational controls. Focus on leading root cause analysis and CAPA, validating sterilization and filtration processes, trending microbiological performance data, and strengthening contamination prevention practices.
Location: Leiden, South Holland, Netherlands
Salary: €68,600–€119,600 annually
Company
Johnson & Johnson MedTech develops healthcare and medical technology solutions across Innovative Medicine and MedTech.
What you will do
- Support the Contamination Control Program for Operations by assessing procedure effectiveness, driving improvements, and maintaining inspection readiness.
- Lead contamination investigations, deep-dive event analysis, root cause analysis, CAPA definition and follow-up, and effectiveness checks.
- Translate microbiological risks into practical facility and process controls, including environmental monitoring, cleaning, disinfection, sanitization, sterilization, and filtration activities.
- Qualify and periodically review environmental monitoring programs, investigate deviations, and trend contamination and leakage performance indicators.
- Deliver training on microbiological hygiene, contamination prevention, and aseptic practices.
- Act as a contamination-control subject matter expert for facility and process design and collaborate with Operations, Quality, the Centre of Expertise, and global stakeholders.
Requirements
- BSc in Microbiology, Biotechnology, Biology, Chemical Engineering, or a similar field; MSc preferred, or equivalent experience.
- Several years of experience in GMP-regulated manufacturing, preferably biopharmaceutical, sterile, or aseptic manufacturing.
- Experience with contamination control and environmental monitoring program design, optimization, qualification, sampling strategies, and trending.
- Working knowledge of GMP expectations, including EU GMP/EudraLex Annex 1 and FDA aseptic processing guidance.
- Experience with root cause analysis, CAPA, deviations, inspection observations, microbiological data interpretation, and KPI development.
- Strong written and verbal English communication skills are required; Dutch is preferred.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and employee merit.
- Annual bonus with a target based on pay grade and location and actual performance.
- Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
- Well-being reimbursement and programs supporting financial, physical, and mental health.
- Recognition awards and participation in applicable insurance plans.
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