4 дня назад
Staff Scientist, Microbiological Quality & Sterility Assurance (MedTech)
64 000 - 103 040€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Staff Scientist, Microbiological Quality & Sterility Assurance (MedTech): Leading microbiological quality and sterility assurance strategies for medical device products, including sterilization validation, aseptic processing, environmental control, and regulatory support with an accent on end-to-end validation and contamination control. Focus on developing sterilization processes, troubleshooting microbiological risks, supporting audits and product launches, and driving remediation across manufacturing sites.
Location: Groningen, Netherlands; minimum 3 days per week onsite with regular travel to other sites and external manufacturers
Base pay: €64,000–€103,040 per year, plus bonus and benefits
Company
Johnson & Johnson MedTech develops healthcare technologies and less invasive, personalized treatments through the combination of biology and technology.
What you will do
- Lead microbiological quality and sterility assurance strategies for Johnson & Johnson Vision products.
- Support new product introductions, method and product validations, transfers, packaging decisions, and regulatory submissions.
- Lead onsite validation of contract sterilization sites, including cycle development, process characterization, and validation.
- Oversee aseptic processing, terminal sterilization, cleanrooms, water systems, environmental monitoring, and microbiological testing.
- Conduct audits, investigations, gap assessments, revalidation activities, and corrective-action support across manufacturing sites.
- Represent MQSA in cross-functional teams, industry associations, standards groups, and technical communities.
Requirements
- Bachelor’s degree in Microbiology, Biology, Engineering, or a related discipline; an advanced degree is preferred.
- At least 8 years of experience in the medical device or pharmaceutical industry within a GMP- and/or ISO-regulated environment.
- Extensive experience with microbiology, sterilization validation, aseptic processing, environmental control, and medical device manufacturing.
- Expertise in multiple sterilization methods, including gas and heat processes, radiation, ethylene oxide, gamma, electron beam, moist heat, and dry heat.
- Experience troubleshooting microbiological and sterilization processes, implementing CAPA, and working with regulatory authorities and external standards.
- Proficiency with Excel, Word, PowerPoint, and analytical software; strong communication, organizational, mentoring, and collaboration skills.
Nice to have
- Master’s degree or PhD in a relevant discipline.
- Experience conducting technical assessments and representing an organization at industry associations.
Culture & Benefits
- Inclusive work environment focused on individual contribution, diversity, and dignity.
- Annual bonus with a target determined by pay grade and location.
- Vacation, 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.
- Insurance plans and service anniversary and recognition awards, subject to applicable plan terms.
- Approximately 50% travel is required.
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