3 дня назад
Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d) (GMP biopharmaceutical manufacturing): Leading and authoring deviation investigations for manufacturing, cleaning, qualification, and operational events with an accent on root cause analysis, impact assessment, and CAPA development. Focus on reconstructing complex technical events, maintaining inspection-ready records, and supporting audits and regulatory inspections.
Location: Visp, Switzerland; primarily site-based
Company
operates a globally connected biopharmaceutical manufacturing network with more than 30 sites across five continents.
What you will do
- Lead and author GMP deviation investigations for manufacturing, cleaning, qualification, and operational events within Module L.
- Reconstruct events, perform fact finding, root cause analysis, recurrence evaluations, impact assessments, and product quality assessments.
- Collaborate with Operations, QA, MSAT, QC, Engineering, Manufacturing Support, and other stakeholders to define CAPAs.
- Drive deviation records through drafting, review, approval, and closure within agreed priorities and timelines.
- Maintain complete, scientifically sound, traceable, inspection-ready records compliant with GMP and site procedures.
- Support audits and customer or regulatory inspections, and contribute to deviation reduction and investigation standardization.
Requirements
- Experience in biotechnology, biopharmaceutical, pharmaceutical, or other GMP-regulated manufacturing environments.
- Experience with deviation investigations, root cause analysis, CAPA management, and quality system processes.
- Strong knowledge of GMP requirements, manufacturing processes, cleaning validation, qualification activities, and quality risk management.
- Ability to analyze complex technical data, assess product and process impact, and develop scientifically justified conclusions.
- Degree in Biotechnology, Bioprocess Engineering, Chemical Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline, or equivalent relevant experience.
- Strong stakeholder communication, organization, prioritization, and technical documentation skills.
Culture & Benefits
- Agile career opportunities and a dynamic working culture.
- Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
- Performance-based compensation programs.
- Professional development through complex GMP investigations, inspection readiness, and continuous improvement initiatives.
- Collaboration with experienced cross-functional teams in a biopharmaceutical manufacturing environment.
- Benefits vary by role and location.
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