For C&Q Technical Lead services.
WHAT MAKES YOU A FIT:
The Technical Part:
- 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 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?
Skills Required
- Bachelor's degree in Automation, Controls, Chemical Engineering, Electrical Engineering, Computer Science, or a related field, or equivalent education and relevant experience
- Excellent reading, writing, and speaking skills in Spanish and English
- Experience providing technical direction on automation system architecture, hardware and software platforms, and programming standards in 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
- Experience performing functional P&ID reviews, leading prototyping activities, and managing technical or engineering changes
- Strong understanding of Computer System Validation principles, GAMP 5 methodology, and ALCOA+ data integrity requirements
- Experience developing and executing C&Q protocols, including IQ/OQ/PQ, and major CSV deliverables
What We Do
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 We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
