CSV Specialist

Carolina, Puerto Rico
Contracted
Pharmaceuticals
Experienced

For MES services in the Business Technology area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor’s Degree and five (5) years of experience or more within the Pharmaceutical & Medical Devices Industry.
  • Bilingual: Spanish and English.
  • Soft Skills: Collaborative attitude and Strong communication skills. 
  • Shift: Administrative and according to business needs.
  • Experience in:
    • MES platforms (Emerson Syncade, including development and maintenance of BI solutions).
    • ​​Computer systems integration and validation experience.
    • Authoring and executing validation documentation (test scripts, protocols, reports). 

The Personality Part:    

  • Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

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 Computerized System in adherence with Site, Regulatory and Client Corporative Requirements.
  • Work both independently, and in a team environment with representatives from Quality, Engineering, Manufacturing Operations and Manufacturing Science & Technology.
  • Work within Office Environment and GMP Controlled Cleanrooms.
  • Work within a Facility that requires high diligence and on occasion to effectively use Personal Protective Equipment (PPE).
  • Coordinate and execute activities as per approved Protocol.
  • Perform computerized systems validation in conformance with cGMP's, plant procedures, corporate policies, and applicable regulations (FDA, DEA, etc.)

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?

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