CSV Engineer
Hace 3 días
Gurabo, Puerto Rico
mirus Consulting Group
Jornada completa
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CSV Engineer
📍 Gurabo, Puerto Rico | Hybrid
mîrus Consulting Group is seeking a CSV Engineer to support Computer System Validation activities in a regulated life sciences environment.
Requirements:
• Bachelor’s degree in Engineering.
• More than five years of experience in Computer System Validation (CSV).
• Knowledge of manufacturing and packaging processes, utilities, facilities, and equipment, including their associated computerized systems.
• Strong knowledge of the complete CSV life cycle, including planning, risk assessments, protocol development and execution, and final reports.
• Knowledge of GAMP 5, FDA 21 CFR Part 11, and applicable GMP requirements.
• Experience preparing and reviewing validation documentation.
• Strong communication, organizational, and problem-solving skills.
• Ability to work independently and collaborate with multidisciplinary teams.
We offer
a competitive hourly rate, a hybrid work arrangement, and a supportive work environment.
Requirements:
• Bachelor’s degree in Engineering.
• More than five years of experience in Computer System Validation (CSV).
• Knowledge of manufacturing and packaging processes, utilities, facilities, and equipment, including their associated computerized systems.
• Strong knowledge of the complete CSV life cycle, including planning, risk assessments, protocol development and execution, and final reports.
• Knowledge of GAMP 5, FDA 21 CFR Part 11, and applicable GMP requirements.
• Experience preparing and reviewing validation documentation.
• Strong communication, organizational, and problem-solving skills.
• Ability to work independently and collaborate with multidisciplinary teams.
We offer
a competitive hourly rate, a hybrid work arrangement, and a supportive work environment.