Job Description

For Computer and System Validation Services.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s Degree in Science (Computer System or Engineering preferred) and six (6) years of exposure in Computer System Validation within Pharmaceutical Industry.
• Excellent communication skills (oral, written and reading) in Spanish and English.
• Shift: Administrative and according to business needs.
• Experience in:
  • Strong hands-on experience leading CSV activities for DeltaV DCS systems within regulated pharmaceutical or biotech environments, including validation lifecycle management and system upgrades.
  • cGMP / 21 CFR Part 11 / GAMP 5 Compliance Expertise.
  • Electronic Validation Execution Tools.

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)

• CSV Lead will be responsible for provide visibility of the overall CSV performance, execution planning, timeline management, and in alignment with the client DeltaV Upgrade Team or other CSV Teams.
• Must have capability to serve as Document Controller for all CSV documentation. All documentation shall be loaded, reviewed, and approved in Quality Docs (Veeva).
• Able to engage with Quality Docs (Veeva) to access and manage all validation documentation.
• Validation shall be executed electronically. All execution resources must be familiar with, or trained in, Application Lifecycle Management (ALM) tools or Kneat . Test scripts will be generated, approved, executed, and verified post-execution a Electronic platform, or any other electronic system in accordance with client procedures.
• Experience in DeltaV DCS platform and associated validation activities.

BEING A FITS PIECE COMES WITH PERKS:

One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!

WHO WE ARE:

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?