Katalyst CRO

Computer System Validation Engineer

4 months ago

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Responsibilities

Execute and lead the validation of computer systems, ensuring compliance with 21 CFR Part 11, FDA regulations, and cGMP regulations.
Develop, review, and approve validation documents, including validation plans, test scripts, and final reports.
Coordinate and conduct validation activities in accordance with project timelines and business objectives.
Implement and manage document control processes and systems.
Evaluate and recommend improvements to existing systems and processes to enhance efficiency and compliance.
Provide technical support and training to other team members on computer system validation and related topics.
Participate in internal and external audits, ensuring all computer systems are compliant.
Oversee ERP implementation, ensuring seamless integration with existing systems.
Stay updated with the latest industry trends, regulations, and validation standards.

Requirements

Bachelor's degree in computer science, Engineering, or a related field.
A minimum of 5 years of experience in Computer System Validation (CSV) in the engineering industry.
Proficient knowledge of Document Control, 21 CFR Part 11, FDA regulations, cGMP regulations, and CSV.
Proven experience in ERP implementation.
Strong understanding of computer systems, including hardware, software, networking, and security.
Excellent problem-solving skills and the ability to handle multiple projects simultaneously.
Strong written and verbal communication skills.
Ability to work in a team and independently as needed.
High attention to detail and accuracy.
Proactive, self-motivated, and able to work under minimal supervision.
Certification in Computer System Validation or a related field would be an added advantage.