13 дней назад
MSAT Expert - Contamination Control (Sterile Manufacturing)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
MSAT Expert - Contamination Control (Sterile Manufacturing): Shaping and driving the Contamination Control Strategy for a greenfield sterile manufacturing facility with an accent on sterility assurance, cleaning validation, APS/Media Fills, EMPQ, and Smoke Studies. Focus on implementing lifecycle validation programs, solving complex contamination-control investigations, and preparing operations for regulatory inspections.
Location: Stein, AG, Switzerland; fully site-based role. Relocation assistance is available for eligible candidates and their families.
Company
develops and manufactures medicines through globally connected life-science sites, with a focus on collaboration, accountability, excellence, passion, integrity, and inclusion.
What you will do
- Act as a subject matter expert for sterility assurance, contamination control, and cleaning validation.
- Implement, maintain, and continuously improve the facility-wide Contamination Control Strategy.
- Lead risk assessments, cross-contamination prevention measures, and contamination-control programs.
- Support APS/Media Fills, Environmental Monitoring Performance Qualification, Smoke Studies, and related validation activities.
- Develop and sustain cleaning-validation protocols and lifecycle programs for equipment, facilities, and manufacturing processes.
- Drive investigations, deviations, CAPAs, continuous improvement, facility start-up, project delivery, and inspection readiness.
Requirements
- Hands-on experience in aseptic drug-product manufacturing, including Fill & Finish operations for vials and/or syringes.
- Expertise in Cleaning Validation or Contamination Control Strategy within sterile drug-product manufacturing.
- Understanding of cleanroom classifications, material flows, HVAC concepts, contamination-control principles, and risk-based assessments.
- Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
- Fluent English communication skills are required.
- Ability to collaborate across technical and operational functions; regulatory-inspection and health-authority experience is advantageous.
Culture & Benefits
- Agile career environment and dynamic work culture.
- Inclusive and ethical workplace.
- Performance-recognition compensation programs.
- Family, lifestyle, and leisure benefits.
- In-person collaboration in a state-of-the-art sterile manufacturing facility.
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