Job Description

Join to apply for the Computer System Validation Specialist role at LABUR

Our client is seeking a Computer System Validation Specialist who will play a crucial role in ensuring that IT systems comply with regulatory guidelines. This role involves the validation process, including creating and executing test plans, documentation, and change control, to maintain data integrity and compliance standards.

Key Responsibilities

• Develop and execute validation protocols for computer systems.
• Ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards.
• Create detailed validation documentation including plans, reports, and scripts.
• Conduct risk assessments and impact analyses related to computer systems.
• Coordinate and supervise testing activities.
• Collaborate with cross-functional teams to maintain and improve system validation processes.
• Monitor and report on validation project progress.
• Provide training and support to staff regarding validation processes and requirements.

Qualifications

• 3+ years of experience in computer system validation.
• Familiarity with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards.
• Strong understanding of software development and validation lifecycle.
• Excellent documentation and technical writing skills.
• Strong analytical and problem-solving capabilities.
• Ability to work independently and in a team environment.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Information Technology
• Industries: IT Services and IT Consulting

Referrals increase your chances of interviewing at LABUR by 2x. Get notified about new Computer Specialist jobs in Bedford, MA .

Interested in other roles? Join our Talent Pool!

Job Tags

Similar Jobs