Description

The IT CSV Analyst will play a crucial role in ensuring the compliance and integrity of computer systems used in a GMP (Good Manufacturing Practice) pharmaceutical environment. This position requires a candidate with a strong background in Computer System Validation to author, review, and implement necessary deliverables for deploying IT systems in such environments. The ideal candidate will leverage their deep understanding of validation principles to ensure regulatory compliance and best practices across local and global IT systems.

Company Culture and Environment

The company fosters a collaborative environment where teamwork and best practices are emphasized. Employees work closely with site organizations and global IT teams to ensure governance and compliance, which indicates a culture of shared responsibility and continuous improvement.

Career Growth and Development Opportunities

This position allows for significant professional growth through collaboration with various teams and the implementation of best practices in validation and data integrity. Employees are encouraged to contribute to corporate objectives and initiatives, which can lead to career advancement opportunities.

Detailed Benefits and Perks

While specific benefits are not detailed, the emphasis on global collaboration and compliance suggests a supportive work environment that may include resource access for continuous learning and development.

Compensation and Benefits

• Competitive salary based on experience
• Comprehensive health benefits
• Opportunities for professional development

Why you should apply for this position today

This role presents an opportunity to significantly impact GMP practices within a leading pharmaceutical environment. By applying your expertise, you will ensure the integrity of vital IT systems and contribute to the overall success of the organization.

Skills

• Strong understanding of Computer System Validation principles
• Knowledge of Data Integrity regulations and best practices
• Excellent communication and collaboration skills
• Ability to author and review validation documentation

Responsibilities

• Author, review and implement Computer System Validation deliverables for IT system deployment in a GMP environment
• Ensure compliance with regulatory requirements and promote sustainability of validation processes
• Collaborate with site organizations and global IT teams to enhance CSV and Data Integrity practices

Qualifications

• Minimum 5 years of experience with Computer System Validations in a GMP pharmaceutical environment
• Proven track record of implementing validation principles effectively

Education Requirements

• Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or a related field

Education Requirements Credential Category

• Software Engineering or a closely related field

Experience Requirements

• 5+ years of experience in Computer System Validations within a GMP pharmaceutical setting

Why work in Concord, NC

Concord, NC offers a blend of historic charm and modern amenities, providing a comfortable and appealing living environment. The city is known for its strong community atmosphere and proximity to Charlotte, allowing for diverse recreational and cultural experiences. Residents enjoy a range of outdoor activities, local dining options, and a rich arts scene, making it an excellent place for both personal and professional growth.