CSV/C&Q Technical Lead — Pharma Automation

Technical Engineering Consulting

Carolina (PR)

On-site

USD 90,000 - 150,000

Full time

6 days ago

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Job summary

Technical & Engineering Consulting LLC seeks an Automation / CSV C&Q Technical Lead to guide validation across a major pharmaceutical capital project in Puerto Rico. You will own CSV strategy, coordinate with engineering and commissioning teams, and ensure compliance from design through handover.

The role requires senior CSV expertise in FDA-regulated environments, with hands-on IQ/OQ/PQ, RTM development, and rigorous documentation.

Qualifications

Bachelor's degree in Automation, Controls, Chemical, Electrical Eng, Computer Science or related.
Significant CSV experience in FDA-regulated environments and capital projects.
Experience leading CSV activities on large projects and with cross-functional teams.

Responsibilities

Lead CSV strategy and technical direction for the project.
Define validation requirements and oversee validation lifecycle.
Collaborate with Process Engineering to align automation with business needs.
Provide leadership during software development, testing, and CQV activities.
Develop and review validation documents (Plans, URS, FDS, FS, RTM, Test Scripts).
Oversee IQ, OQ, PQ execution and support FAT/SAT activities.
Manage deviations, change controls, and validation records.
Create CSV training plans and monitor milestones and deliverables.