Validation Specialist
Validation Specialist
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Job Description
At Inteldot we specialize in delivering high-quality systems integration and staff augmentation services to clients in the life sciences industry. We are currently seeking experienced Validation Specialists to join our growing team and support projects across the LATAM region.
Position Summary:
The Validation Specialist will be responsible for providing validation services in support of projects related to equipment utilities facilities processes and computer systems. The ideal candidate will have hands-on experience in one or more of the following areas:
Commissioning and Qualification (C&Q)
Process Validation
Computer System Validation (CSV)
Cleaning Validation
Risk Assessments Protocol Development and Execution
Regulatory compliance (FDA EMA GAMP 5 etc.)
Key Responsibilities:
Develop and execute validation protocols (IQ/OQ/PQ PV CSV etc.)
Review and analyze data and documentation to ensure compliance with regulatory and client standards
Collaborate with cross-functional teams to ensure timely project execution
Provide technical support and guidance to client teams
Requirements:
Bachelors degree in Engineering Life Sciences or related field
Minimum of 3 years of experience in validation within the pharmaceutical biotechnology or medical device industries
Knowledge of current industry regulations and best practices (cGMP FDA GAMP etc.)
Strong communication and documentation skills
Ability and willingness to travel within the LATAM region and work in a hybrid model (remote and onsite as required)
Bilingual in Spanish and English
Required Experience:
Unclear Seniority
Employment Type
Full-Time
