Are you our match?

We’re looking for 2 IT Specialists. If you’ve got the skills, we’d like to hear from you!

Job Type: Contract 6 months

Starting Date: December 2024

Location: South Area, Puerto Rico

IT Specialist Job description:

• Responsible for managing, maintaining, and optimizing network infrastructure and virtual machine environments within biopharmaceutical operations.
• Ensures that IT systems are secure, reliable, and compliant with industry regulations such as GxP and cGMP.
• Collaborates with cross-functional teams in the remediation activities for the manufacturing processes, troubleshoot IT issues, and implement network and virtualization solutions that enhance operational efficiency.
• Support the management and maintenance activities for the network infrastructure and virtual machine environments.
• Ensure system security, performance, and compliance with GxP and cGMP standards.
• Troubleshoot network and virtual machine issues in manufacturing systems.
• Collaborate with automation, IT, and engineering teams to optimize infrastructure.
• Support system upgrades, backups, and disaster recovery planning.
• Experience with network administration and virtual machine environments.

IT Specialist Compliance Job description:

• Responsible for ensuring that all IT systems and processes within the biopharmaceutical environment comply with regulatory standards, including GxP, cGMP, and FDA guidelines.
• Focuses on managing and overseeing Computer System Validation (CSV) activities, ensuring that IT systems are validated and meet the required compliance standards.
• Works closely with IT, quality assurance, and regulatory teams to support audits, documentation, and continuous improvement initiatives.
• Lead and manage Computer System Validation (CSV) processes for IT systems.
• Ensure compliance with GxP, cGMP, FDA, and other regulatory standards.
• Collaborate with IT and quality teams to maintain validated systems.
• Support internal and external audits by ensuring proper documentation.
• Implement and monitor IT compliance programs and continuous improvement initiatives.
• Experience in IT compliance and CSV in the biopharmaceutical industry.
• Strong understanding of GxP, cGMP, FDA regulations, and validation processes.
• Excellent documentation and audit readiness skills.

Compensation:

Competitive market compensation will be based on experience.

To apply, please send resume to vicky.paz@principiapr.com