Computer Systems Validation Specialist

Job Details

Manage computerized system validation activities in CRL Manufacturing Operations, ensuring compliance and quality in equipment and software. Responsible for documentation maintenance and serving as a resource for validation team members, contractors, and vendors.

Responsibilities:

• Lead full lifecycle of validation projects, delivering on time and to specification.
• Write and review validation deliverables (e.g., Validation Plans, Summary Reports).
• Develop and update test validation procedures in compliance with regulatory requirements.
• Maintain current Systems Inventory and validation documentation.
• Archive validation documentation as per procedures.
• Assist in writing SOPs for the Validation Department.
• Coordinate installation, maintenance, and repair of computerized systems.
• Facilitate project meetings and produce related documentation (e.g., meeting minutes).
• Train and support staff on validation projects.
• Manage cross-functional teams and provide project updates.
• Communicate project expectations clearly and timely to team members and stakeholders.
• Assist other departments with validation requirements as needed.
• Report Quality Management System non-compliances to Senior Management.
• Plan and schedule project timelines and milestones.
• Implement solutions to validation issues.
• Present validation systems program during audits.
• Perform other related duties as assigned.

Job Qualifications:

• Education: Bachelors degree in computer science, scientific, or related discipline.
• Experience: 5-7 years in Computer System Validation; experience in GxP laboratory preferred.
• Certification/Licensure: Test or validation certification desired.
• Other: Comprehensive knowledge of regulatory requirements (e.g., GxPs, 21 CFR Part 11, Annex 11). Strong organizational and analytical skills, ability to adapt to changing environments.

 Charles River Laboratories

 07/04/2024

 Wayne,PA