CSV Engineer - Tampa, United States - Lifelancer

Description

About the job CSV Engineer

Responsibilities:

• Manage and execute Computer System Validation (CSV) activities for various systems, including Laboratory Information Management Systems (LIMS) and related software.
• Develop and implement CSV protocols, test scripts, and validation plans in compliance with regulatory standards, including FDA and GxP guidelines.
• Conduct risk assessments and gap analyses to ensure systems comply with industry regulations and company standards.
• Collaborate with cross-functional teams to ensure that CSV activities align with project timelines and business objectives.
• Provide technical expertise and guidance on CSV-related issues, offering solutions to ensure the integrity and reliability of computerized systems.
• Participate in the validation of equipment, processes, and systems, including the qualification of hardware and software components as needed.
• Generate comprehensive documentation and reports related to CSV activities, ensuring accuracy and completeness of records.

• Bachelor's degree in Computer Science, Engineering, or a related field.
• Minimum of 5 years of experience in CSV within the life sciences industry.
• Strong knowledge of regulatory requirements, including FDA guidelines and GxP standards.
• Proficiency in validating Laboratory Information Management Systems (LIMS) and related software.
• Excellent problem-solving and analytical skills, with the ability to identify and address compliance issues effectively.
• Proven experience in developing and executing validation protocols and test scripts.
• Effective communication skills and the ability to collaborate with cross-functional teams.
• Detail-oriented with a strong commitment to maintaining the highest quality standards.
• Familiarity with data integrity and cybersecurity standards within a regulated environment.