Computer System Validation Engineer - Katalyst CRO : Job Details

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• 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.

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.

Seniority level

• Seniority levelAssociate

Employment type

• Employment typeContract

Job function

• IndustriesPharmaceutical Manufacturing

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