Validation and Compliance Engineer
hace 2 semanas
About Mentor Technical Group:
Mentor Technical Group provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, we have the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.
Responsibilities:
- Evaluate and determine if utility systems, process maintenance, instrumentation/calibration/electrical systems and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards.
- Participate in the coordination of TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical and process automation issues.
- Assist during FDA and other regulatory agency inspections.
- Provide TECHSUPPORT in response to the FDA and other regulatory agencies.
Required Skills:
- Leadership and teambuilding
- Verbal communication
- Written Communication/Technical Writing
- Organization
- Facilitation
- Comprehensive understanding of validation protocol requirements.
- Technical (Equipment Specific)
- Analytical Problem Solving
We Offer:
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
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