Automation/CSV - C&Q Technical Lead

FITS, LLC; Carolina (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS, LLC in Puerto Rico is seeking a CSV/QA professional to lead commissioning and qualification for automation and control systems in a regulated environment. You will develop validation plans, design and test scripts, and ensure data integrity per ALCOA+ and GAMP 5.

You will coordinate with QA, automation, and commissioning teams, manage deviations and change controls, and prepare CSV training materials. Fluent in Spanish and English is required.

Qualifications

• Bachelor's degree or equivalent in a technical field.
• Bilingual in Spanish and English (reading/writing/speaking).
• Shift: Administrative and according to business needs.
• Experience in automation systems within pharma/biotech or regulated capital projects.
• Experience reviewing control system documentation and vendor documentation.
• Knowledge of data historians, batch reporting, and MES.

Responsibilities

• Partner with process engineering to align requirements with business needs.
• Lead CSV strategy, validation plans, and major deliverables (IQ/OQ/PQ, Design, Test Plans).
• Coordinate CSV activities with QA, Automation Engineering, and Commissioning teams.
• Develop and maintain CSV documentation compliant with GAMP 5 and Lilly procedures.
• Support FAT/SAT execution and system handover to client teams.
• Provide CSV input to schedule and milestone tracking.
• Manage deviations, discrepancies, and change controls.
• Develop CSV training materials and matrices for the team.

Skills

Automation architecture

CSV & GAMP5

IQ/OQ/PQ validation

Documentation management

ALCOA+ data integrity

Change control

Cross-functional collaboration

Spanish/English bilingual

Education

Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science, or related field

Job description

• Bachelor's 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 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 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 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 industryclients with top-notch quality talent.We're FITS!