The Senior Equipment & System Specialist will manage the lifecycle of equipment across point-of-care facilities in the US, ensuring compliance and efficient functionality. Initial onboarding and training will be conducted in Belgium (client-funded travel).
Key Responsibilities:
- Deploy new instruments within Point of Care Manufacturing network
- Coordinate and oversee instrument qualification and maintenance
- Ensure data integrity and user management compliance
- Review vendor documentation (IOQ, PQ) and write lifecycle documents (URS, IQ, OQ, PQ)
- Conduct root-cause analysis and implement corrective actions for deviations
Qualifications:
- BSc/MSc in Life Sciences, Biotechnology, Engineering, or related field with 5-10 years of experience
- Knowledge of cGMP equipment lifecycle requirements, GMP, ICH guidelines, and ATMP regulations
- Experience with computer system validations (preferred)
- Strong communication skills; fluent in English
- US-based, willing to travel up to 50% (key locations: Boston, San Francisco, San Diego)
Attributes:
- Quality-driven, adaptable to changing priorities, and fosters continuous improvement
