CSV Lead

For Computer and System Validation Services.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelors 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 youre able to analyze data so that not a single inconsistency gets past you (which allows you to be an amazing problem-solver). Youre 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 were 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 CSVperformance execution planning timeline management and in alignment withthe clientDeltaV Upgrade Team or other CSV Teams.
• Must have capability to serve asDocument Controller for all CSV documentation. All documentation shall beloaded reviewed and approved in Quality Docs (Veeva).
• Able to engage with Quality Docs (Veeva) to access and manage all validationdocumentation.
• Validation shall be executed electronically. Allexecution resources must be familiar with or trained in Application LifecycleManagement (ALM) tools or Kneat . Test scripts will be generated approvedexecuted and verified post-execution a Electronic platform or any otherelectronic system in accordance with clientprocedures.
• 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 youll be amazed). However thats not all we have to offer. Talk with us to find out!

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece