CSV Specialist

For Computer and System Validation support services in the Business Insights and Technology Department 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Engineering, Computer Systems or related disciplines, combined with at least five (5) years of CSV and Change Control Management within a Pharmaceutical / Biotechnology Environment. 
• Experience in:
  • Change Control Management 
  • Reading and interpreting drawings and design specifications, or any other technical document. 
  • Computers and software packages
  • GMP, local/federal regulatory requirements, and documentation procedures pertaining to the pharmaceutical manufacturing plant. 

The Personality Part:    

• Besides being an CSV Pro, you’re able to analyze data so that not a single inconsistency gets past you (which allows you to be an amazing problem-solver). You’re also a skilled multitasker with an incredible ability to set priorities. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, and you might just be what we’re looking for!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Developing and managing Change Control records from initiation through closure, including system release for use, impact assessment, and endorsement.
• Performing Computerized System Validation (CSV) activities in accordance with established standard procedures.
• Communicating task progress, roadblocks, and unmet requirements to leadership.
• Collaborating with cross-functional teams to review and update project-related documentation.
• Developing testing protocols in Application Lifecycle Management (ALM) and other necessary documentation.
• Coordinating meetings with technical and multidisciplinary teams for document development and revision.
• Developing, approving, and/or executing the following CSV deliverables: CSV Risk Assessments, Site Risk Assessments, Validation Plans, Data Integrity/Data Mapping Assessments, Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), System User Requirements Specifications, System Specifications (Design and/or Functional Specifications), Configuration Specifications, Design Review Evaluations, Data Migration (if applicable), Initial and Final Traceability Matrices, Installation Qualification (IQ) and Operational Qualification (OQ) protocol tests and reports, Validation Plan Summary Reports, and Administration and Security Standard Operating Procedures (SOPs).
• Revising Backup and Disaster Recovery SOPs as needed.
• Updating Inventory Lists.
• Submitting and supporting Cybersecurity Assessments.
• Managing document control activities, including downloading, uploading, developing, updating, reviewing, and approving documents within document management systems.
• Completing and documenting required training, submitting forms, addressing comments, and scheduling/conducting follow-up meetings to ensure timely completion of tasks.

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the next piece?