AutomationCSV C&Q Technical Lead

For C&Q Technical Leadservices.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelors degree in Automation Controls Chemical/Electrical Engineering Computer Science or a related field or an equivalent combination of education and relevant experience.
• Excellent reading writing and speaking skills in Spanish and English.
• Shift: Administrative and according to business needs
• Experience in:
  • Demonstrated experience providing technical direction on automation system architecture hardware/software platforms and programming standards within a pharmaceutical biotech or comparable regulated capital-project environment.
  • Experience reviewing control system and packaged equipment vendor documentation and supporting automation hardware software and licensing procurement.
  • Working knowledge of data historians batch reporting systems and manufacturing execution systems (MES).
  • Experience performing functional P&ID reviews leading prototyping activities and managing technical/engineering changes.
  • Strong understanding of Computer System Validation (CSV) principles GAMP 5 methodology and data integrity (ALCOA) requirements.
  • Experience developing and executing C&Q protocols (IQ/OQ/PQ) and major CSV deliverables including validation plans requirements traceability matrices test scripts and summary reports.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family especially our resources clients and team other words being a customer service pro is one your (many) talents. Being the Piece means youre full of bright ideas and eager to innovate always bringing top-quality results to the table. Are you ready to take on this new challenge

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

• Partner with process engineering to ensure automation requirements are aligned with business needs.
• Manage technical changes and provide technical direction through all software development and testing activities.
• Partner with the Design Verification Lead to ensure alignment between CSV and verification expectations.
• Provide direction for CSV strategy validation approach and major CSV deliverables (Requirements Design Security Plan Test Plan etc.).
• Lead development and execution of Commissioning and Qualification (C&Q) protocols (IQ/OQ/PQ) for automation and control systems.
• Develop all related CSV documentation (validation plans requirements traceability matrices test scripts summary reports) ensuring it complies with GAMP 5 and applicable specifications and Lilly quality system procedures.
• Coordinate CSV activities with Quality Assurance Automation Engineering and Commissioning teams to support project schedule and data integrity requirements.
• Manage deviations discrepancies and change controls associated with C&Q and CSV activities.
• Develop and maintain CSV training materials and matrices for the CSV team automation integrator CSV service provider and Client USER groups.
• Support FAT/SAT execution and assist with system handover to the Client USER team.
• Provide CSV input to the C&Q schedule and progress reporting including system definition/classification and baseline CSV milestones.

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