Senior Computer System Validation Engineer

This job was posted over 30 days ago, so it has most likely closed. See newer jobs like it.

Written by AI from the job title and company, not by Celito Tech, Inc., so some details may not match this job. The employer's own page has the real description.

Job Overview

The Senior Computer System Validation Engineer at Celito Tech, Inc. will be responsible for ensuring that all computer systems and software used in quality-critical processes are validated and in compliance with industry standards. This role includes designing and executing validation plans, managing risk assessments, and collaborating with cross-functional teams to ensure that documentation meets regulatory requirements. The successful candidate will also lead auditing activities and provide training to junior team members, ensuring adherence to best practices in system validation.

Job Responsibilities

• Develop and execute validation plans, protocols, and summary reports for computer systems.
• Conduct risk assessments and maintain a risk-based validation approach in compliance with industry standards.
• Collaborate with internal teams to understand system requirements and translate them into validation documentation.
• Participate in system design reviews and contribute validation expertise to ensure systems are built to compliance standards.
• Lead and document deviations, change controls, and root cause analyses related to system validation issues.
• Provide mentorship and training to junior validation engineers and quality assurance personnel.
• Prepare for and conduct internal and external audits, ensuring all validation activities are inspection-ready.
• Continuously improve validation processes and methodologies to enhance efficiency and effectiveness.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or a related field; master's degree preferred.
• Minimum of 5 years of experience in computer system validation within a regulated environment.
• In-depth knowledge of FDA regulations, GxP guidelines, and relevant industry best practices.
• Strong analytical and problem-solving skills with a keen attention to detail.
• Excellent written and verbal communication skills, with the ability to convey technical information clearly.
• Proficiency in validation tools and methodologies.
• Ability to work collaboratively in a team-oriented environment.

Technologies & Tools

The Senior Computer System Validation Engineer will utilize various technologies and tools such as validation management software, electronic document management systems, risk assessment frameworks, and statistical analysis tools. Familiarity with computerized systems used in manufacturing, clinical, and laboratory environments is essential. Experience with programming languages and database management systems may also be beneficial to effectively assess system functionality during the validation process.

Ideal Candidates

The ideal candidate for the Senior Computer System Validation Engineer position will possess a blend of technical expertise and strong interpersonal skills. They should demonstrate exceptional analytical abilities, critical thinking, and a proactive approach to problem-solving. The candidate must be detail-oriented, capable of managing multiple priorities simultaneously while maintaining a high standard of quality in their work. A commitment to upholding regulatory compliance and a collaborative spirit to work effectively with cross-functional teams will also define the right fit for this role.