CSV Engineer

mirus Consulting Group; Gurabo (PR); Hybrid; USD 55,000 - 83,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive hourly rate

Job summary

mîrus Consulting Group is seeking a CSV Engineer to support Computer System Validation activities in a regulated life sciences environment. This role requires deep experience in the CSV lifecycle and compliance practices.

We offer a competitive hourly rate, a hybrid work arrangement, and a collaborative work environment that values independent work and cross-functional teamwork.

Qualifications

• Extensive experience in Computer System Validation (CSV).
• Knowledge of GAMP 5, FDA 21 CFR Part 11 and GMP requirements.
• Experience preparing and reviewing validation documentation.

Skills

Communication

Organizational skills

Problem-solving

Education

Bachelor’s degree in Engineering

Job description

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.