CSV Specialist

For Computer and System Validation services in the Engineering area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in engineering or science with five (5) years of experience in computerized system validation of the pharmaceutical or biopharmaceutical industry.
• Experience in:
  • Design and execution of compliant and efficient validation strategies for system and equipment. 
  • Development of a technically competent and focused customer service-oriented team. 
  • Ensure that timely and adequate computerized system validation is performed in conformance with cGMP’s plant procedures, corporate policies, and applicable regulations (FDA, ENEA, DEA, etc.) 
  • Prioritizes projects and schedules as needed. 
  • Provides guidance for determining work procedures, preparation of work schedule, and expediting of workflow.

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)

• Define and execute strategies for IT Computerized Systems, Computerized System
  Validation and Data Integrity Compliance for Computerized Systems.
• Design and execute Validation Plans and Protocols for Computerized Systems. Perform data integrity risk assessment for new and existing computerized systems.
• Execute Periodic Review activities for the Computerized System in adherence with Site, Regulatory, and Client Corporate Requirements.
• Work both independently and in a team environment with representatives from Quality, Engineering, Manufacturing Operations, and Manufacturing Science & Technology.
• Work within the Office Environment and GMP Controlled Cleanrooms.
• Work within a Facility that requires high diligence and, on occasion, use Personal Protective Equipment (PPE) effectively.
• Coordinate and execute activities as per the approved Protocol.
• Perform computerized systems validation in conformance with cGMPs, plan procedures, corporate policies, and applicable regulations (FDA, DEA, etc.)

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?